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

NCT02836028 | Withdrawn Phase 2

• 1 other identifier: MDV3800-11
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Determine Objective Response Rate (ORR)

  Anticipated in about 44 months following first patient enrolled

Secondary Outcomes (9)

• Progression-free survival (PFS)

  Anticipated in about 44 months following first patient enrolled

• PFS at 24 weeks

  Anticipated in about 44 months following first patient enrolled

• Gynecologic Cancer Intergroup (GCIG) CA125 response rate

  Anticipated in about 44 months following first patient enrolled

• Clinical benefit rate at 24 weeks

  Anticipated in about 44 months following first patient enrolled

• Duration of response (DOR)

  Anticipated in about 44 months following first patient enrolled

Study Arms (2)

talazoparib

EXPERIMENTAL

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

Drug: Talazoparib

talazoparib + temozolomide

ACTIVE COMPARATOR

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

Drug: Talazoparib; Drug: Temozolomide

Interventions

Talazoparib DRUG

Talazoparib monotherapy 1mg/day orally

Also known as: MDV3800, BMN673

talazoparib; talazoparib + temozolomide

Temozolomide DRUG

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

talazoparib + temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Myriad Genetic Laboratories, Inc.: collaborator
• Medivation, Inc.: collaborator

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

talazoparib; Temozolomide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 18, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2020
• Last Updated: September 18, 2018

Record last verified: 2018-09