Open-Label Extension and Safety Study of Talazoparib

A SINGLE-ARM, OPEN-LABEL, MULTICENTER, EXTENDED TREATMENT, SAFETY STUDY IN PATIENTS TREATED WITH TALAZOPARIB

This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Talazoparib

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • Juravinski Cancer Clinic
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
• France
  • Marseille cedex 09, France, 13273
    • Institut Paoli-Calmettes
• Germany
  • Erlangen, Germany, 91054
    • Frauenklinik des Universitaetsklinikums Erlangen
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
  • Budapest, Hungary, H-1122
    • Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai Osztaly es Klinikai Farmakologiai Osztaly
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, MD-2025
    • Arensia Exploratory Medicine, Institutia Medico-Sanitara Publica Institutul Oncologic
• Poland
  • Warszawa, Poland, 02-801
    • Szpital LUX MED
• Russian Federation
  • Moscow, Russian Federation, 119991
    • FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
  • Saint-Petersburg, Russian Federation, 196105
    • Medical Technologies LLC
• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden NHS Foundation Trust
• United States
  • California
    • Alhambra, California, United States, 91801
      • UCLA Hematology/Oncology - Alhambra
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
    • Burbank, California, United States, 91505
      • UCLA Hematology/Oncology - Burbank
    • Fullerton, California, United States, 92835
      • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • Los Angeles, California, United States, 90095
      • TRIO-US Central Administration
    • Los Angeles, California, United States, 90095-7349
      • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
    • Los Angeles, California, United States, 90095
      • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
    • Los Angeles, California, United States, 90095
      • (IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center
    • Pasadena, California, United States, 91105
      • UCLA Hematology/Oncology - Pasadena
    • Porter Ranch, California, United States, 91326
      • UCLA Hematology/Oncology - Porter Ranch
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology - Santa Monica
    • Torrance, California, United States, 90505
      • UCLA Torrance Oncology
    • Valencia, California, United States, 91355
      • UCLA Hematology/Oncology - Santa Clarita
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc.
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Hospital West
  • Indiana
    • Bloomington, Indiana, United States, 47403
      • IU Health Bloomington Hospital
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology, Inc.
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Medical Oncology and Hematology, Inc.
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital
    • Indianapolis, Indiana, United States, 46202
      • Investigational Drug Senvices
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Talazoparib	Drug: Talazoparib; Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol; Other Names: MDV3800

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)
Number of Participants With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4	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.	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)
Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death	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.	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)
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests	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.	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)
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters	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.	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)
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters	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.	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)
Number of Participants With Clinically Significant Changes in Vital Signs and Weight	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.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Medivation, Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2016
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Talazoparib
• Other Study ID Numbers: MDV3800-13; C3441010 (Other Identifier: Alias Study Number); 2016-001972-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.