Open-Label Extension and Safety Study of Talazoparib
- Registration Number
- NCT02921919
- Lead Sponsor
- Pfizer
- Brief Summary
This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through 45 days after the last dose.
- Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of talazoparib through 105 days after the last dose. Contraception should be considered for a nonpregnant female partner of childbearing potential.
- Female patients may not be breastfeeding at the first dose of talazoparib and must not breastfeed during study participation through 45 days after the last dose of talazoparib.
- Permanently discontinued from any Medivation sponsored study with talazoparib alone or in combination with another agent.
- Received an antineoplastic therapy or investigational agent after treatment with talazoparib in the originating protocol.
- Has a clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or pulmonary disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator.
- Diagnosis of myelodysplastic syndrome (MDS).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Talazoparib Talazoparib -
- Primary Outcome Measures
Name Time Method Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years) The following hematology parameters were analyzed: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Laboratory toxicities were graded using NCI-CTCAE version 4 where, grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death) for each parameter. Number of participants with Grade 3 and 4 toxicities were reported. Low indicates values lower than the normal range.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years) An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death; inpatient hospitalization or prolongation of existing hospitalization; was life-threatening (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or was considered as an important medical event. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. AE included both SAEs and all non-SAEs. Treatment-related TEAEs were defined as any TEAE with at least a possible relationship to the study drug as assessed by the investigator or that was missing the assessment of causal relationship whose relationship to the study drug could not be ruled out.
Number of Participants With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4 From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years) An AE was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. Severity was graded using NCI-CTCAE version 4 where, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 3 or 4 TEAEs were reported.
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years) The following liver parameters were analyzed: aspartate transaminase (AST), alanine aminotransferase (ALT), total bilirubin (TBL) and alkaline phosphatase (ALP). The criteria for clinically significant abnormalities for liver parameters included AST or ALT greater than or equal to (\>=) 3 times upper limit of normal (ULN); ALT or AST greater than (\>) 5 times ULN; ALT or AST \> 10 times ULN; ALT or AST \> 20 times ULN; total TBL \>2 times ULN; ALT or AST \>= 3 times ULN and TBL \> 2 times ULN and ALT or AST \>= 3 times ULN and TBL \> 2 times ULN and ALP \< 2 times ULN.
Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years) An AE was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. Number of participants with TEAEs leading to dose reduction, permanent study drug discontinuation and death were reported.
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years) The following chemistry parameters were analyzed: alkaline phosphatase, bilirubin and creatinine. Laboratory toxicities were graded using NCI-CTCAE version 4 where, grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death) for each parameter. Number of participants with Grade 3 or 4 toxicities were reported. High indicates values higher than the normal range.
Number of Participants With Clinically Significant Changes in Vital Signs and Weight From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years) Criteria for clinically significant changes in vital signs included a) Systolic blood pressure (SBP): 1) absolute results \>180 millimeter of mercury (mmHg) and increase from baseline \>=40 mmHg, 2) absolute results \<90 mmHg and decrease from baseline \>30 mmHg; b) Diastolic blood pressure (DBP): 1) absolute results \>110 mmHg and increase from baseline \>=30 mmHg , 2) absolute results \<50 mmHg and decrease from baseline \>20 mmHg , 3) increase from baseline \>=20 mmHg; c) Heart rate: 1) absolute results \>120 beats per minute (bpm) and increase from baseline \>30 bpm, 2) absolute results \<50 bpm and \>20 bpm decrease from baseline; d) Temperature: \<=34.5 or \>=38 degree Celsius. Criteria for clinically significant changes in weight: \>10 percent (%) decrease from baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
UCLA Hematology/Oncology - Burbank
🇺🇸Burbank, California, United States
TRIO-US Central Administration
🇺🇸Los Angeles, California, United States
UCLA Hematology/Oncology
🇺🇸Los Angeles, California, United States
Memorial Hospital West
🇺🇸Pembroke Pines, Florida, United States
Indiana University Health Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Investigational Drug Senvices
🇺🇸Indianapolis, Indiana, United States
IU Health University Hospital
🇺🇸Indianapolis, Indiana, United States
Arensia Exploratory Medicine, Institutia Medico-Sanitara Publica Institutul Oncologic
🇲🇩Chisinau, Moldova, Republic of
IU Health Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
(IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center
🇺🇸Los Angeles, California, United States
UCLA Hematology/Oncology - Alhambra
🇺🇸Alhambra, California, United States
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
🇺🇸Los Angeles, California, United States
Institut Paoli-Calmettes
🇫🇷Marseille cedex 09, France
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
UCLA Hematology/Oncology - Porter Ranch
🇺🇸Porter Ranch, California, United States
UCLA Hematology/Oncology - Santa Monica
🇺🇸Santa Monica, California, United States
UCLA Torrance Oncology
🇺🇸Torrance, California, United States
UCLA Hematology/Oncology - Santa Clarita
🇺🇸Valencia, California, United States
Orlando Health, Inc.
🇺🇸Orlando, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc.
🇺🇸Fort Wayne, Indiana, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Juravinski Cancer Clinic
🇨🇦Hamilton, Ontario, Canada
Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
🇭🇺Budapest, Hungary
Frauenklinik des Universitaetsklinikums Erlangen
🇩🇪Erlangen, Germany
FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
🇷🇺Moscow, Russian Federation
Royal Marsden NHS Foundation Trust
🇬🇧Sutton, Surrey, United Kingdom
Medical Technologies LLC
🇷🇺Saint-Petersburg, Russian Federation
UCLA Hematology/Oncology - Pasadena
🇺🇸Pasadena, California, United States
Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai Osztaly es Klinikai Farmakologiai Osztaly
🇭🇺Budapest, Hungary
Szpital Lux Med
🇵🇱Warszawa, Poland