Open-Label Extension and Safety Study of Talazoparib

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921919
• Other study ID #: MDV3800-13
• Secondary ID: C34410102016-001
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2016
• Est. completion date: July 20, 2021

Study information

• Verified date: July 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Talazoparib
Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Clinic	Hamilton	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
France	Institut Paoli-Calmettes	Marseille cedex 09
Germany	Frauenklinik des Universitaetsklinikums Erlangen	Erlangen
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly	Budapest
Hungary	Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai Osztaly es Klinikai Farmakologiai Osztaly	Budapest
Moldova, Republic of	Arensia Exploratory Medicine, Institutia Medico-Sanitara Publica Institutul Oncologic	Chisinau
Poland	Szpital Lux Med	Warszawa
Russian Federation	FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF	Moscow
Russian Federation	Medical Technologies LLC	Saint-Petersburg
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey
United States	UCLA Hematology/Oncology - Alhambra	Alhambra	California
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center	Bakersfield	California
United States	IU Health Bloomington Hospital	Bloomington	Indiana
United States	UCLA Hematology/Oncology - Burbank	Burbank	California
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare	Fullerton	California
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
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	(IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center	Los Angeles	California
United States	TRIO-US Central Administration	Los Angeles	California
United States	UCLA Hematology/Oncology	Los Angeles	California
United States	UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.	Los Angeles	California
United States	UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.	Los Angeles	California
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Orlando Health, Inc.	Orlando	Florida
United States	UCLA Hematology/Oncology - Pasadena	Pasadena	California
United States	Memorial Hospital West	Pembroke Pines	Florida
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

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Moldova, Republic of,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

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