MedPath

Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

Phase 3
Terminated
Conditions
Ovarian Cancer
Interventions
Drug: Farletuzumab-matched placebo
Registration Number
NCT00849667
Lead Sponsor
Morphotek
Brief Summary

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
1100
Inclusion Criteria
  • A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
  • Must have measurable disease by CT or MRI scan
  • Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy
  • Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
  • Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
  • Must be a candidate for carboplatin and taxane therapy
  • Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1
Exclusion Criteria
  • Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
  • Subjects who have received other therapy to treat their ovarian cancer since relapse
  • Known central nervous system (CNS) tumor involvement
  • Evidence of other active invasive malignancy requiring treatment in the past 5 years
  • Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
  • Previous treatment with MORAb-003 (farletuzumab)
  • Clinical contraindications to use of a taxane

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboFarletuzumab-matched placeboParticipants will receive farletuzumab-matched placebo (0.9 percent \[%\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.
Farletuzumab (1.25 mg/kg)TaxaneParticipants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \[AUC\] 5-6 milligram per milliliter per minute \[mg/mL/minute\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.
PlaceboTaxaneParticipants will receive farletuzumab-matched placebo (0.9 percent \[%\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.
Farletuzumab (2.5 mg/kg)TaxaneParticipants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.
Farletuzumab (1.25 mg/kg)CarboplatinParticipants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \[AUC\] 5-6 milligram per milliliter per minute \[mg/mL/minute\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.
Farletuzumab (2.5 mg/kg)CarboplatinParticipants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.
PlaceboCarboplatinParticipants will receive farletuzumab-matched placebo (0.9 percent \[%\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.
Farletuzumab (2.5 mg/kg)FarletuzumabParticipants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.
Farletuzumab (1.25 mg/kg)FarletuzumabParticipants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \[AUC\] 5-6 milligram per milliliter per minute \[mg/mL/minute\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.
Primary Outcome Measures
NameTimeMethod
Progression-free Survival (PFS)From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors \[RECIST\]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With Length of Second Remission Greater Than First RemissionFrom the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)

Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

Duration of Tumor ResponseFrom the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)

Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.

Overall Survival (OS)From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)

OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.

Cancer Antigen-125 (CA-125) Progression-Free SurvivalFrom the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (\>=) 2 multiple (\*) ULN with either event documented on two occasions or CA-125 \>=2\*nadir value with either event documented on two occasions.

Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) CriteriaFrom the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 \>=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 \>=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 \>=two times ULN on two occasions at least one week apart.

Time to Tumor Response (TTR)From the date of randomization to first documentation of objective response (up to 48 months)

Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.

Percentage of Participants With Serologic Response (SR)Up to 48 months

SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.

Time to 50% Serologic Response (TSR)From the date of randomization to first documentation of 50% SR (up to 48 months)

TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

Vd: Volume of Distribution of Total Carboplatin and Total PaclitaxelCycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) ScoresCycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)

Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.

Percentage of Participants With Objective ResponseFrom the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)

Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

Duration of 50% Serologic ResponseFrom the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)

Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total PaclitaxelCycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total PaclitaxelCycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Percentage of Participants With Clinical BenefitUp to 48 months

Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.

Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total PaclitaxelCycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
T1/2: Terminal Half-life of Total Carboplatin and Total PaclitaxelCycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
CL: Clearance of Total Carboplatin and Total PaclitaxelCycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

Trial Locations

Locations (342)

Hematology Oncology P.C.

🇺🇸

Stamford, Connecticut, United States

Loyola University Chicago

🇺🇸

Maywood, Illinois, United States

Mercy Medical Center

🇺🇸

Baltimore, Maryland, United States

Sparrow Regional Cancer Center

🇺🇸

Lansing, Michigan, United States

John Hopkins University

🇺🇸

Baltimore, Maryland, United States

Weinberg Cancer Institute at Franklin Square

🇺🇸

Baltimore, Maryland, United States

Kettering Medical Center

🇺🇸

Kettering, Ohio, United States

Baylor Sammons Cancer Center

🇺🇸

Dallas, Texas, United States

The Moncton Hospital

🇨🇦

Moncton, New Brunswick, Canada

Magee-Womens Hospital of UPMC

🇺🇸

Pittsburgh, Pennsylvania, United States

University Hospitals of Cleveland

🇺🇸

Cleveland, Ohio, United States

University of Texas Health Science Center at Houston Medical School

🇺🇸

Houston, Texas, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

Utah Cancer Specialists

🇺🇸

Salt Lake City, Utah, United States

Morristown Memorial Hospital

🇺🇸

Morristown, New Jersey, United States

CER Instituto Medico

🇦🇷

Quilmes, Argentina

St. Joseph's Hospital, Barrow Neurology Clinics

🇺🇸

Phoenix, Arizona, United States

Alexandra Hospital

🇬🇷

Athens, Greece

Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

🇭🇺

Veszprém, Hungary

Gynecologic Oncology Associates

🇺🇸

Newport Beach, California, United States

General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

🇬🇷

Athens, Greece

Cooper Cancer Institute

🇺🇸

Voorhees, New Jersey, United States

Jawaharlal Nehru Cancer Hospital & Research Centre

🇮🇳

Bhopal, Madhya Pradesh, India

Kursk Regional Oncology Centre

🇷🇺

Kursk, Russian Federation

Moscow Research Oncology Institute n.a. P.A.Gertsen

🇷🇺

Moscow, Russian Federation

Tata Memorial Hospital

🇮🇳

Mumbai, India

Linn Medical Center, Clalit Health Services

🇮🇱

Haifa, Israel

Shaare Zedek Medical Center

🇮🇱

Jerusalem, Israel

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet

🇭🇺

Szolnok, Hungary

Rabin Medical Center

🇮🇱

Petach Tikva, Israel

Kaplan Medical Center

🇮🇱

Rehovot, Israel

Academisch Ziekenhuis Maastricht

🇳🇱

Maastricht, Netherlands

KK Women's and Children's Hospital

🇸🇬

Singapore, Singapore

Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"

🇺🇦

Cherkasy, Ukraine

Russian Oncology Research Center named after N.N. Blokhin

🇷🇺

Moscow, Russian Federation

Taipei Veterans General Hospital

🇨🇳

Taipei, Taiwan

Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii

🇵🇱

Olsztyn, Poland

Hospital de São João

🇵🇹

Porto, Portugal

The Chaim Sheba Medical Center

🇮🇱

Ramat-Gan, Israel

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

🇵🇱

Poznan, Poland

Medical Radiology Research Center of RAMS

🇷🇺

Obninsk, Russian Federation

Chernivtsi Regional Clinical Oncology Dispansery

🇺🇦

Chernivtsi, Ukraine

University Of Alabama At Birmingham

🇺🇸

Birmingham, Alabama, United States

Humanitas Centro Catanese di Oncologia

🇮🇹

Catania, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

🇮🇹

Meldola, Italy

Azienda Ospedaliero-Universitaria di Udine

🇮🇹

Udine, Italy

Oregon Health & Science University

🇺🇸

Portland, Oregon, United States

Kaiser Permanente Northwest

🇺🇸

Portland, Oregon, United States

Providence St. Joseph Medical Center

🇺🇸

Burbank, California, United States

Arizona Oncology Associates

🇺🇸

Tucson, Arizona, United States

University of California San Diego

🇺🇸

La Jolla, California, United States

California Cancer Care, Inc.

🇺🇸

Greenbrae, California, United States

Jupiter Medical center Physician's Group

🇺🇸

Jupiter, Florida, United States

Catholic Health Initiatives

🇺🇸

Cincinnati, Ohio, United States

Denver Health and Hospital Authority

🇺🇸

Denver, Colorado, United States

Hematology/Oncology Associates

🇺🇸

Lake Worth, Florida, United States

Oncology-Hematology Associates of W. Broward P.A.

🇺🇸

Tamarac, Florida, United States

Palm Beach Cancer Institute

🇺🇸

West Palm Beach, Florida, United States

Central DuPage Hospital

🇺🇸

Winfield, Illinois, United States

Hematology & Oncology Specialists

🇺🇸

Metairie, Louisiana, United States

Greater Baltimore Medical Center

🇺🇸

Baltimore, Maryland, United States

Saint Mary's Health Care

🇺🇸

Grand Rapids, Michigan, United States

Frederick Memorial Hospital

🇺🇸

Frederick, Maryland, United States

Barbara Ann Kamanos Cancer Center

🇺🇸

Detroit, Michigan, United States

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

Hematology-Oncolgy Associates of NNJ-PA

🇺🇸

Denville, New Jersey, United States

University of New Mexico Cancer Center

🇺🇸

Albuquerque, New Mexico, United States

John Theurer Cancer Center at Hackensack University MC

🇺🇸

Hackensack, New Jersey, United States

Good Samaritan Hospital Cancer Center

🇺🇸

Kearney, Nebraska, United States

The Center for Cancer and Hematologic Disease

🇺🇸

Camden, New Jersey, United States

SUNY Upstate Medical University

🇺🇸

Syracuse, New York, United States

Carolinas Medical Center

🇺🇸

Charlotte, North Carolina, United States

Presbyterian Hospital

🇺🇸

Charlotte, North Carolina, United States

Willamette Valley Cancer Center

🇺🇸

Springfield, Oregon, United States

Providence Oncology & Hematology Care

🇺🇸

Portland, Oregon, United States

Cancer Care Associates

🇺🇸

Tulsa, Oklahoma, United States

Texas Oncology, PA

🇺🇸

Dallas, Texas, United States

Peninsula Cancer Institute - Riverside Gynecology Oncology

🇺🇸

Newport News, Virginia, United States

St. Luke's Hospital

🇺🇸

Bethlehem, Pennsylvania, United States

Gettysburg Cancer Center

🇺🇸

Gettysburg, Pennsylvania, United States

Western Pennsylvania Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

Northern Utah Associates

🇺🇸

Ogden, Utah, United States

South Texas Oncology and Hematology, PA

🇺🇸

San Antonio, Texas, United States

Scott and White Memorial Hospital

🇺🇸

Temple, Texas, United States

International Beneficence Clinical Research, L.L.C.

🇺🇸

Harlingen, Texas, United States

US Oncology Research

🇺🇸

Wichita Falls, Texas, United States

Northern Virginia Pelvic Surgery Associates

🇺🇸

Annandale, Virginia, United States

Hospital Bocalandro

🇦🇷

Loma Hermosa, Argentina

Consultorios Medicos Privados SA

🇦🇷

Buenos Aries, Argentina

Instituto Medico Platense

🇦🇷

La Plata, Argentina

Providence Everett Medical Center

🇺🇸

Everett, Washington, United States

Cancer Care Northwest-South

🇺🇸

Spokane, Washington, United States

Aurora Health Care

🇺🇸

West Allis, Wisconsin, United States

Fundación Sanatorio Güemes

🇦🇷

Caba, Argentina

Clinica Universitaria Reina Fabiola

🇦🇷

Códoba, Argentina

Centro Oncologico Riojano Integral (CORI)

🇦🇷

La Rioja, Argentina

Centro Médico San Roque

🇦🇷

San Miguel de Tucuman, Argentina

UZ Leuven

🇧🇪

Leuven, Belgium

Tweed Hospital

🇦🇺

Tweed Heads, New South Wales, Australia

North Adelaide Oncology Clinical Trials

🇦🇺

North Adelaide, South Australia, Australia

Centro Medico de Alta Complejidad Cemac

🇦🇷

San Salvador de Jujuy, Argentina

Landeskrankenhaus Villach

🇦🇹

Villach, Austria

ISIS Centro Especializado de LUCE SA

🇦🇷

Santa Fe, Argentina

Kaiser-Franz-Josef Spital

🇦🇹

Wien, Austria

Krankenhaus Wien-Hietzing

🇦🇹

Wien, Austria

Institut Jules Bordet

🇧🇪

Bruxelles, Belgium

Sir Charles Gairdner Hospital

🇦🇺

Nedlands, Western Australia, Australia

AZ Groeninge - Campus Maria's Voorzienigheid

🇧🇪

Kortrijk, Belgium

Associação Hospital de Caridade Ijuí

🇧🇷

Ijuí, Brazil

Clinica de Neoplasias Litoral

🇧🇷

Itajai, Brazil

Instituto Ribeirãopretano de Combate ao Câncer

🇧🇷

Ribeirão Preto, Brazil

UZ Gent

🇧🇪

Gent, Belgium

CHU de Liège

🇧🇪

Liège, Belgium

Instituto de Pesquisas Clínicas para Estudos Multicêntricos

🇧🇷

Caxias do Sul, Brazil

Liga Norte-Riograndense Contra o Câncer

🇧🇷

Natal, Brazil

Sint-Augustinuskliniek

🇧🇪

Wilrijk, Belgium

Fundação Pio XII - Hospital de Câncer de Barretos

🇧🇷

Barretos, Brazil

Clínica AMO - Assistência Multidiciplinar em Oncologia

🇧🇷

Salvador, Brazil

Saúde ABC Serviços Médicos Hospitalares Ltda

🇧🇷

Santo André, Brazil

Tom Baker Cancer Centre

🇨🇦

Calgary, Alberta, Canada

Cancer Center For The Southern Interior

🇨🇦

Kelowna, British Columbia, Canada

Hospital Premier

🇧🇷

São Paulo, Brazil

British Columbia Cancer Agency

🇨🇦

Surrey, British Columbia, Canada

BCCA

🇨🇦

Vancouver, British Columbia, Canada

Krankenhaus Nordwest

🇩🇪

Frankfurt, Germany

Ottawa Hospital

🇨🇦

Ottawa, Ontario, Canada

Ninewells Hospital

🇬🇧

Dundee, United Kingdom

Universitätsklinikum Essen

🇩🇪

Essen, Germany

Instituto Oncologico Ltda.

🇨🇱

Viña del Mar, Chile

Institut Paoli Calmettes

🇫🇷

Marseille, France

Hôpital Saint Louis

🇫🇷

Paris Cedex 10, France

Frauenarztpraxis Dr. med. Gröll de Rivera

🇩🇪

Ebersberg, Germany

Bács-Kiskun Megyei Önkormányzat Kórháza

🇭🇺

Kecskemét, Hungary

Papageorgiou General Hospital

🇬🇷

Thessaloniki, Greece

Queen Mary Hospital

🇭🇰

Pokfulam, Islands, Hong Kong

Istituto Nazionale dei Tumori

🇮🇹

Milano, Italy

Regional Cancer Centre

🇮🇳

Trivandrum, India

Albert Schweitzer Ziekenhuis

🇳🇱

Dordrecht, Netherlands

Orbis Medisch Centrum

🇳🇱

Sittard-Geleen, Netherlands

Cebu Gynecologic Cancer Care Clinic

🇵🇭

Cebu, Philippines

Ospedale Mater Salutis ULSS 21 della regione Veneto

🇮🇹

Legnago, Italy

Fondazione Centro San Raffaele del Monte Tabor

🇮🇹

Milano, Italy

Union Medica Quirurgica de Colima

🇲🇽

Colima, Mexico

Presidio Ospedaliero Vito Fazzi

🇮🇹

Lecce, Italy

Azienda Ospedaliera Niguarda Cà Granda

🇮🇹

Milano, Italy

Cheil General Hospital & Women's Healthcare Center

🇰🇷

Seoul, Korea, Republic of

Seoul national univercity hospital

🇰🇷

Seoul, Korea, Republic of

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

🇮🇹

Milano, Italy

VU Medisch Centrum

🇳🇱

Amsterdam, Netherlands

Manila Doctors Hospital

🇵🇭

Manila, Philippines

Ospedale Santa Maria della Misericordia di Perugia

🇮🇹

Perugia, Italy

Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"

🇮🇹

Napoli, Italy

Ospedale Sacro Cuore Don Calabria

🇮🇹

Negrar, Italy

Istituto Oncologico Veneto

🇮🇹

Padova, Italy

Arcispedale Santa Maria Nuova

🇮🇹

Reggio Emilia, Italy

Perpetual Succour Hospital

🇵🇭

Cebu City, Cebu, Philippines

San Juan de Dios Hospital

🇵🇭

Pasay City, Philippines

Wojewodzkie Centrum Onkologii

🇵🇱

Gdansk, Poland

Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach

🇵🇱

Gliwice, Poland

Centrum Onkologii Ziemi Lubelskiej

🇵🇱

Lublin, Poland

Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.

🇵🇱

Olsztyn, Poland

Wielkopolskie Centrum Onkologii

🇵🇱

Poznan, Poland

Azienda Policlinico Umberto I

🇮🇹

Roma, Italy

Policlinico Universitario "A. Gemelli"

🇮🇹

Roma, Italy

Ospedale Santa Maria delle Croci

🇮🇹

Ravenna, Italy

St. Luke's Medical Center

🇵🇭

Quezon City, Philippines

National Kidney and Transplant Institute

🇵🇭

Quezon City, Philippines

Bialostockie Centrum Onkologii

🇵🇱

Bialystok, Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

🇵🇱

Lodz, Poland

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Volyn Regional Oncology Dispensary

🇺🇦

Lutsk, Ukraine

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

🇵🇱

Rybnik, Poland

Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie

🇵🇱

Szczecin, Poland

Hospitais da Universidade de Coimbra

🇵🇹

Coimbra, Portugal

Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare

🇷🇺

Ufa, Russian Federation

National University Hospital

🇸🇬

Singapore, Singapore

National Cancer Centre

🇸🇬

Singapore, Singapore

Hospital Mutua de Terrassa

🇪🇸

Terrassa, Cataluña, Spain

Wojskowy Instytut Medyczny

🇵🇱

Warszawa, Poland

Russian Oncology Research Center

🇷🇺

Moscow, Russian Federation

Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)

🇵🇹

Lisboa, Portugal

Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE

🇵🇹

Coimbra, Portugal

Chang Gung Memorial Hospital

🇨🇳

Taoyuan, Taiwan

Beatson Oncology Centre

🇬🇧

Glasgow, United Kingdom

Leicester Royal Infirmary

🇬🇧

Leicester, United Kingdom

Santa Casa da Misericórdia de Curitiba

🇧🇷

Curitiba, Brazil

Instituto do Câncer do Ceará - ICC

🇧🇷

Fortaleza, Brazil

Irmandade Santa Casa de Misericórdia de Porto Alegre

🇧🇷

Porto Alegre, Brazil

Hosp. Araujo Jorge

🇧🇷

Goiania, Brazil

Hospital Amaral Carvalho

🇧🇷

Jaú, Brazil

Clínica de Oncologia de Porto Alegre S/S Ltda

🇧🇷

Porto Alegre, Brazil

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

🇧🇷

Salvador, Brazil

Centro de Estudos de Oncologia da FMABC

🇧🇷

Santo André, Brazil

National Cancer Center

🇰🇷

Gyeonggi-do, Korea, Republic of

Severance Hospital, Yonsei University College of Medicine

🇰🇷

Seoul, Korea, Republic of

Gachon University Gil Medical Center

🇰🇷

In Cheon, Korea, Republic of

Klinikum Traunstein

🇩🇪

Traunstein, Germany

Rotkreuzklinikum München

🇩🇪

München, Germany

University of Colorado

🇺🇸

Aurora, Colorado, United States

Center for Cancer and Blood Disorders

🇺🇸

Bethesda, Maryland, United States

Hospital Virgen del Rocio

🇪🇸

Sevilla, Andalucía, Spain

Hospital Universitario Reina Sofia

🇪🇸

Córdoba, Andalucía, Spain

Hospital de Mataró

🇪🇸

Mataró, Cataluña, Spain

Hospital Clinic i Provincial

🇪🇸

Barcelona, Cataluña, Spain

Corporació Sanitaria Parc Taulí

🇪🇸

Sabadell, Cataluña, Spain

Hospital General Universitario Gregorio Marañon

🇪🇸

Madrid, Madrid, Communidad De, Spain

Hospital Clinico San Carlos

🇪🇸

Madrid, Spain

Hospital Universitario Ramón y Cajal

🇪🇸

Madrid, Madrid, Communidad De, Spain

Hospital 12 de Octubre

🇪🇸

Madrid, Madrid, Communidad De, Spain

Stanford University

🇺🇸

Stanford, California, United States

Sarasota Memorial Healthcare System

🇺🇸

Sarasota, Florida, United States

Medical College of Georgia

🇺🇸

Augusta, Georgia, United States

Gulfcoast Oncology

🇺🇸

Saint Petersburg, Florida, United States

Ingalls Memorial Hospital

🇺🇸

Harvey, Illinois, United States

Memorial Health University Medical Center

🇺🇸

Savannah, Georgia, United States

St. Francis Hospital & Health Centers

🇺🇸

Indianapolis, Indiana, United States

MetroHealth Medical Center

🇺🇸

Cleveland, Ohio, United States

Harrison Bremerton Hematology and Oncology

🇺🇸

Bremerton, Washington, United States

Signal Point Clinical Research Center, LLC

🇺🇸

Middletown, Ohio, United States

Westmead Hospital

🇦🇺

Westmead, New South Wales, Australia

University of California Davis Cancer Center

🇺🇸

Sacramento, California, United States

Piedmont Hematology & Oncology

🇺🇸

Winston-Salem, North Carolina, United States

St. Vincent Gynecologic Oncology

🇺🇸

Indianapolis, Indiana, United States

Certo Oncologia

🇧🇷

São Paulo, Brazil

Instituto do Câncer Arnaldo Vieira de Carvalho

🇧🇷

São Paulo, Brazil

Arizona Hematology & Oncology Associates

🇺🇸

Phoenix, Arizona, United States

Oncology Specialties, PC

🇺🇸

Huntsville, Alabama, United States

Arizona Cancer Center

🇺🇸

Tucson, Arizona, United States

University of California Los Angeles Medical Center

🇺🇸

Los Angeles, California, United States

Palm Beach Institute of Hematology and Oncology

🇺🇸

Boynton Beach, Florida, United States

Washington Hospital Center

🇺🇸

Washington, District of Columbia, United States

University Cancer Institute

🇺🇸

Boynton Beach, Florida, United States

Lakeland Regional Cancer Center

🇺🇸

Lakeland, Florida, United States

Medical & Surgical Specialists, LLC

🇺🇸

Galesburg, Illinois, United States

Midwest Cancer Research Group

🇺🇸

Skokie, Illinois, United States

Park Nicollet Institute

🇺🇸

Saint Louis Park, Minnesota, United States

Saint Francis Memorial Health Center

🇺🇸

Grand Island, Nebraska, United States

Arena Oncology Associates

🇺🇸

Lake Success, New York, United States

Roswell Park Cancer Institute

🇺🇸

Buffalo, New York, United States

Columbia University Medical Center

🇺🇸

New York, New York, United States

Miami Valley Hospital

🇺🇸

Dayton, Ohio, United States

Oncology Hematology Associates

🇺🇸

DuBois, Pennsylvania, United States

Chattanooga's Program in Women's Oncology

🇺🇸

Chattanooga, Tennessee, United States

Abington Memorial Hospital

🇺🇸

Abington, Pennsylvania, United States

Texas Oncology, P.A.

🇺🇸

Bedford, Texas, United States

Hospital Zonal Especializado en Oncología de Lanús

🇦🇷

Buenos Aires, Argentina

Centro Oncologico Integral

🇦🇷

Mar Del Plata, Argentina

Mater Adult Hospital

🇦🇺

South Brisbane, Queensland, Australia

The Royal Brisbane and Women's Hospital

🇦🇺

Herston, Queensland, Australia

Cliniques Universitaires Saint-Luc

🇧🇪

Bruxelles, Belgium

Clínica Oncologistas Associados

🇧🇷

Rio de Janeiro, Brazil

INCA - Instituto Nacional do Câncer

🇧🇷

Rio De Janeiro - RJ, Brazil

Instituto de Terapias Oncologicas

🇨🇱

Santiago, Chile

Instituto Clínico Oncológico del Sur

🇨🇱

Temuco, Chile

Centre Régional de lutte contre le cancer Paul Papin

🇫🇷

Angers Cedex 9, France

Centre Hospitalier Louis Pasteur

🇫🇷

Le Coudray, France

Klinikum Chemnitz gGmbH

🇩🇪

Chemnitz, Germany

Institut Jean Godinot - Centre de lutte contre le cancer

🇫🇷

Reims, France

Charité - Universitätsmedizin Berlin

🇩🇪

Berlin, Germany

Helios Klinikum Berlin-Buch

🇩🇪

Berlin-Buch, Germany

Marien-Hospital Akademisches Lehrkrankenhaus

🇩🇪

Düsseldorf, Germany

Universitätsklinikum Freiburg

🇩🇪

Freiburg, Germany

Kath. Marienkrankenhaus gGmbH

🇩🇪

Hamburg, Germany

Universität Heidelberg

🇩🇪

Heidelberg, Germany

Klinikum der Universität München - Innenstadt

🇩🇪

München, Germany

Universitätsklinik Magdeburg

🇩🇪

Magdeburg, Germany

St. Vincentius Kliniken Karlsruhe

🇩🇪

Karlsruhe, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

🇩🇪

Mainz, Germany

Klinikum Südstadt Rostock

🇩🇪

Rostock, Germany

University General Hospital of Patras

🇬🇷

Patras, Greece

University General Hospital of Heraklion

🇬🇷

Heraklion, Crete, Greece

Semmelweis Egyetem

🇭🇺

Budapest, Hungary

Tuen Mun Hospital

🇭🇰

Tuen Mun, Hong Kong

Petz Aladár Megyei Oktató Kórház

🇭🇺

Gyor, Hungary

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

🇭🇺

Miskolc, Hungary

Apollo Hospitals International Limited

🇮🇳

Gandhinagar, Gujarat, India

Kidwai Memorial Institute of Oncology

🇮🇳

Bangalore, Karnataka, India

Jehangir, Clinical Development Centre

🇮🇳

Pune, Maharashtra, India

MNJ Institute of Oncology and Regional Cancer Centre

🇮🇳

Hyderabaad, India

Dr. Kamakshi Memorial Hospital

🇮🇳

Chennai, Tamil Nadu, India

Chittaranjan National Cancer Institute

🇮🇳

Kolkata, West Bengal, India

M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board

🇮🇳

Bangalore, India

Amrita Institute of Medical Sciences and Research Centre

🇮🇳

Cochin, India

Bhagwan Mahaveer Cancer Hospital and Research Centre

🇮🇳

Jaipur, India

SK Soni Hospital

🇮🇳

Jaipur, India

Lakeshore Hospital

🇮🇳

Kochi, India

Curie Manavata Cancer Centre

🇮🇳

Nasik, India

Shatabdi Superspeciality Hospital

🇮🇳

Nashik, India

Rambam Medical Center

🇮🇱

Haifa, Israel

Wolfson Centre

🇮🇱

Holon, Israel

All India Institute of Medical Sciences

🇮🇳

New Delhi, India

Hadassah University Hospital Ein Kerem

🇮🇱

Jerusalem, Israel

Meir Medical Center

🇮🇱

Kfar Saba, Israel

Assaf Harofe Medical Center

🇮🇱

Zerifin, Israel

Centro di Riferimento Oncologico

🇮🇹

Aviano, Pordenone, Italy

Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo

🇮🇹

Alessandria, Italy

Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche

🇮🇹

Campobasso, Italy

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

🇮🇹

Bologna, Italy

Istituto Ospedaliero Fondazione Poliambulanza

🇮🇹

Brescia, Italy

Azienda Ospedaliera Cannizzaro

🇮🇹

Catania, Italy

Azienda Ospedaliera Sant'Anna

🇮🇹

Como, Italy

Ospedale di Faenza

🇮🇹

Faenza, Italy

Azienda Ospedaliera Universitaria San Martino

🇮🇹

Genova, Italy

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Triva Investigaciones Medicas Sociedad Anónima de Capital Variable

🇲🇽

Morelia, Mexico

Hospital Regional de Veracruz

🇲🇽

Veracruz, Mexico

Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

🇵🇹

Porto, Portugal

City Clinical Oncology Dispensary

🇷🇺

St. Petersburg, Russian Federation

Ryazan Regional Clinical Oncology Dispensary

🇷🇺

Ryazan, Russian Federation

Hospital Son Llatzer

🇪🇸

Palma de Mallorca, Baleares, Spain

Hospital Universitario Vall D'Hebron

🇪🇸

Barcelona, Cataluna, Spain

Fundación Instituto Valenciano de Oncología

🇪🇸

Valencia, Comunidad Valenciana, Spain

Hospital General Universitario de Elche

🇪🇸

Elche, Comunidad Valenciana, Spain

Fundacion Hospital Alcorcon

🇪🇸

Alcorcón, Madrid, Communidad De, Spain

National Cheng Kung University Hosptial

🇨🇳

Tainan, Taiwan

Universität Zürich

🇨🇭

Zürich, Switzerland

Mackay Memorial Hospital

🇨🇳

Taipei, Taiwan

Tri-Service General Hospital

🇨🇳

Taipei, Taiwan

Kiev City Oncology Hospital

🇺🇦

Kyiv, Ukraine

Velindre Hospital

🇬🇧

Cardiff, United Kingdom

University Hospital Coventry

🇬🇧

Coventry, United Kingdom

Belfast City Hospital

🇬🇧

Belfast, United Kingdom

Royal Marsden Hospital

🇬🇧

London, United Kingdom

Hammersmith Hospital

🇬🇧

London, United Kingdom

Derriford Hospital

🇬🇧

Plymouth, United Kingdom

Poole Hospital NHS Trust

🇬🇧

Poole, United Kingdom

Clatterbridge Centre For Oncology

🇬🇧

Wirral, United Kingdom

Weston Park Hospital

🇬🇧

Sheffield, United Kingdom

New Cross Hospital

🇬🇧

Wolverhampton, United Kingdom

Gainsville Hematology Oncology Associates

🇺🇸

Gainesville, Florida, United States

Florida Hospital

🇺🇸

Orlando, Florida, United States

Kaiser Permanente - Moanalua Medical Center

🇺🇸

Honolulu, Hawaii, United States

Kapi'olani Medical Center for Women and Children

🇺🇸

Honolulu, Hawaii, United States

Central Baptist Hospital

🇺🇸

Lexington, Kentucky, United States

University of Louisville

🇺🇸

Louisville, Kentucky, United States

Norton Healthcare

🇺🇸

Louisville, Kentucky, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Baptist Cancer Institute

🇺🇸

Jacksonville, Florida, United States

Northwest Cancer Specialists, PC

🇺🇸

Vancouver, Washington, United States

Ruby Hall Clinic

🇮🇳

Pune, Maharashtra, India

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