An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Interventions
- Registration Number
- NCT01363479
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 743
- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
- Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of equal or more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents.
- If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion.
- If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following cisplatin or on any subsequent study day.
- ECOG Performance Status of 0, 1, or 2
- Female patients of either non-childbearing potential or child-bearing potential with a commitment to use contraceptive methods throughout the clinical trial
- Hematologic and metabolic status adequate for receiving a highly emetogenic cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
- If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of the Investigator.
- If a patient has a known history or predisposition to cardiac conduction interval abnormalities he/she may be enrolled in this study at the discretion of the Investigator.
- If female, pregnant or lactating.
- Current use of illicit drugs or current evidence of alcohol abuse.
- Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to Day 5 following cisplatin administration.
- Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1 week prior to Day 1 or between Days 1 to 5.
- Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
- Symptomatic primary or metastatic CNS malignancy.
- Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical conditions (other than malignancy) that, in the opinion of the investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks in administering the study drugs to the patient.
- Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone.
- Participation in a clinical trial involving palonosetron.
- Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug during the study.
- Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its equivalent are permitted.
- Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
- Any medication with known or potential antiemetic activity within 24 hours prior to Day 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral palonosteron plus dexamethasone Oral palonosetron Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Oral palonosteron plus dexamethasone Dexamethasone Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. I.V. palonosetron plus dexamethasone I.V. palonosetron Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. I.V. palonosetron plus dexamethasone Dexamethasone Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
- Primary Outcome Measures
Name Time Method Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication 0-24 hours
- Secondary Outcome Measures
Name Time Method Percentage of Patients With no Emesis 0-24 hours Percentage of Patients With no Rescue Medication 0-24 hours
Trial Locations
- Locations (79)
Facey Medical Group
🇺🇸Mission Hills, California, United States
Northern Utah Associates [Hematology/ Oncology]
🇺🇸Ogden, Utah, United States
Genesis Cancer Centre
🇺🇸Hot Springs, Arkansas, United States
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
🇷🇴Cluj-Napoca, Romania
GUZ Arkhangelsk Regional Clinical Oncological Dispensary
🇷🇺Arkhangelsk, Russian Federation
GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
🇷🇺Lipetsk, Russian Federation
Complex Oncology Centre
🇧🇬Stara Zagora, Bulgaria
Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)
🇷🇴Cluj-Napoca, Romania
Szpital Wojewodzki Zespolony
🇵🇱Elblag, Poland
Clínica Universitaria Reina Fabiola
🇦🇷Córdoba, Argentina
Wellmont Medical Associates-Oncology and Hematology
🇺🇸Bristol, Rhode Island, United States
Sri Venkateshwara Hospital [Medical Oncology]
🇮🇳Bangalore, India
Klinicka bolnica [Sestre milosrdnice]
🇭🇷Zagreb, Croatia
Instituto Médico CER [Oncology]
🇦🇷Quilmes, Argentina
Specialised Hospital for Active treatment on Oncology
🇧🇬Sofia, Bulgaria
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
KBC Rijeka
🇭🇷Rijeka, Croatia
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
🇵🇱Lodz, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
🇵🇱Warszawa, Poland
Instituto Oncológico de Córdoba (IONC)
🇦🇷Cordoba, Argentina
Sanatorio Parque
🇦🇷Rosario, Argentina
MHAT Dr. Tota Venkova
🇧🇬Gabrovo, Bulgaria
District Dispensery for Oncology Diseases with in-patient
🇧🇬Sofia, Bulgaria
Klinicki bolnicki centar [Oncology]
🇭🇷Osijek, Croatia
KBC Zagreb
🇭🇷Zagreb, Croatia
Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
🇺🇦Dnipropetrovsk, Ukraine
DU IMR AMNU [vd khemter]
🇺🇦Kharkiv, Ukraine
Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged
🇭🇺Kecskemet, Hungary
UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
🇧🇬Sofia, Bulgaria
Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
🇮🇳Pune, Maharashtra, India
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
🇵🇱Lomza, Poland
Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
🇺🇦Chernihiv, Ukraine
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
🇷🇴Baia-Mare, Romania
Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad
🇺🇦Donetsk, Ukraine
Apollo Speciality Hospital
🇮🇳Chennai, Tamil Nadu, India
Fondazione Poliambulanza Istituto Ospedaliero
🇮🇹Brescia, Italy
Presidio Ospedaliero "Alessandro Manzoni"
🇮🇹Lecco, Italy
AO Regionale S.Carlo di Potenza
🇮🇹Potenza, Italy
Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]
🇷🇴Sibiu, Romania
Chinmaya Mission Hospital
🇮🇳Bangalore, India
Institutul Regional de Oncologie Iasi
🇷🇴Iasi, Romania
Yashoda Super speciality Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
🇷🇴Bucharest, Romania
Centrul de Oncologie Euroclinic
🇷🇴Iasi, Romania
OncoResearch Lerchenfeld UG
🇩🇪Hamburg, Germany
Städtisches Klinikum München
🇩🇪München, Germany
RAMN - Russian Cancer Research Center
🇷🇺Moscow, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin RAMN
🇷🇺Moscow, Russian Federation
GUZ Regional Oncology Dispensary #2
🇷🇺Magnitogorsk, Russian Federation
St. Petersburg Clinical Oncology Dispesary
🇷🇺Saint Petersburg, Russian Federation
Centro Medico San Roque
🇦🇷San Miguel de Tucuman, Argentina
Semmelweis Egyetem Kútvölgyi Klinikai Tömb
🇭🇺Budapest, Hungary
Petz Aladár Megyei Oktató Kórház
🇭🇺Györ, Hungary
Compassionate Cancer Center
🇺🇸Corona, California, United States
Compassionate Cancer Centre Medical Group
🇺🇸Fountain Valley, California, United States
Compassionate Cancer Care Medical Group
🇺🇸Riverside, California, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Centro Oncológico Integral (COI)
🇦🇷Mar del Plata, Buenos Aires, Argentina
ISIS Clinica Especializada
🇦🇷Santa Fe, Argentina
Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department
🇧🇬Sofia, Bulgaria
Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte
🇩🇪Berlin, Germany
Staedtisches Krankenhaus Muenchen Neuperlach
🇩🇪München, Germany
Fővárosi Önkormányzat Uzsoki utcai Kórház
🇭🇺Budapest, Hungary
City Cancer Centre [Surgical and Medical Oncology]
🇮🇳Vijayawada, India
Pécsi Tudományegyetem [Onkoterápiás Intézet]
🇭🇺Pécs, Hungary
Ospedale Vito Fazzi - ASL Lecce
🇮🇹Lecce, Italy
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
🇭🇺Szolnok, Hungary
NZOZ Magodent - Centrum Medczyne Ostrobramska
🇵🇱Warszawa, Poland
Oncomed SRL
🇷🇴Timisoara, Romania
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
🇵🇱Slupsk, Poland
GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
🇷🇺Krasnoyarsk, Russian Federation
MBUZ City Clinical Hospital #1 [Oncology]
🇷🇺Novosibirsk, Russian Federation
FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF
🇷🇺Obninsk, Russian Federation
GUZ Leningrad Regional Oncological Dispensary
🇷🇺Saint Petersburg, Russian Federation
Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
🇷🇺Ryazan, Russian Federation
Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
🇺🇦Kharkiv, Ukraine
Opca bolnica Varazdin
🇭🇷Varazdin, Croatia
Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
🇺🇦Khmelnytskyi, Ukraine
Uzhgorod National University
🇺🇦Uzhgorod, Ukraine