A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

NCT ID: NCT02836028

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31

Brief Summary

The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal cancer.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

talazoparib

Cohorts 1A (PARP inhibitor naïve), 2A (PARP inhibitor sensitive), and 3A (PARP inhibitor refractory)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Talazoparib monotherapy 1mg/day orally

talazoparib + temozolomide

Cohorts 1B (PARP inhibitor naïve), 2B (PARP inhibitor sensitive), and 3B (PARP inhibitor refractory)

Group Type: ACTIVE_COMPARATOR

Talazoparib

Intervention Type: DRUG

Talazoparib monotherapy 1mg/day orally

Temozolomide

Intervention Type: DRUG

temozolomide 37.5 mg/m2 on days 1-5 of each cycle

Interventions

Talazoparib

Talazoparib monotherapy 1mg/day orally

Intervention Type: DRUG

Temozolomide

temozolomide 37.5 mg/m2 on days 1-5 of each cycle

Intervention Type: DRUG

Other Intervention Names

MDV3800; BMN673

Eligibility Criteria

Inclusion Criteria

• Women ≥ 18 years of age and willing and able to provide informed consent
• Relapsed, histologically confirmed ovarian, fallopian tube, and peritoneal cancer. Histologic subtypes include serous, endometrioid, clear-cell, mixed, undifferentiated histology, and carcinosarcoma.
• Sufficient archival tumor tissue available or consent to a fresh tissue biopsy for biomarker analysis. Consent to blood sample collection for biomarker analysis is required.
• Disease progression per RECIST 1.1 during or after the last treatment. Have metastatic disease with at least 1 target tumor lesion measurable per RECIST 1.1 on the screening scan. Lesions used for biopsies cannot be designated as a measurable lesion for RECIST 1.1 assessments.
• Additional criteria for cohort 1 include the following:
• Have a deleterious germline or a somatic BRCA1 or BRCA2 mutation, or a high diagnostic HRD test score (myChoice score ≥ 42), which represents a loss of DNA repair function based on testing performed at a sponsor-approved laboratory
• Received at least 1 and no more than 3 platinum-based chemotherapy regimens (prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization
• No prior PARP inhibitor treatment (COHORT 1 ONLY)
• Additional criteria for cohorts 2 and 3 include the following:
• Received at least 2 platinum-based chemotherapy regimens (including first-line chemotherapy; prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization
• Received prior PARP inhibitor treatment as a single agent or in combination therapy regimen and the last dose is ≥ 28 days before randomization, as follows:
• For cohort 2 only: Received PARP inhibitor treatment for ≥ 6 months and had a response of CR, PR, or stable disease for ≥ 6 months
• For cohort 3 only: Received PARP inhibitor treatment for < 6 months with no response (disease progression or stable disease)
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Estimated life expectancy of ≥ 3 months.
• Able to swallow drugs, have no known intolerance to study drugs or excipients, and able to comply with study requirements.

Exclusion Criteria

• Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
• Use of any investigational agent within 14 days before randomization.
• Had > 2 paracentesis procedures within 28 days before randomization.
• Major surgery within 14 days before randomization.
• Requirement for intravenous alimentation (at the time of randomization).
• Diagnosis of MDS.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: collaborator

Medivation, Inc.

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

MDV3800-11

Identifier Type: -

Identifier Source: org_study_id