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

Ovarian Cancer Clinical Trial

Official title:

A Phase 2, Multiple-Cohort, Open-Label, International Study of Talazoparib Monotherapy and Talazoparib Plus Temozolomide in Women With Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02836028
• Other study ID #: MDV3800-11
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2016

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer

Intervention

Drug:
• Talazoparib
Talazoparib monotherapy 1mg/day orally
• Temozolomide
temozolomide 37.5 mg/m2 on days 1-5 of each cycle

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc., Myriad Genetic Laboratories, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine Objective Response Rate (ORR)		Anticipated in about 44 months following first patient enrolled
Secondary	Progression-free survival (PFS)		Anticipated in about 44 months following first patient enrolled
Secondary	PFS at 24 weeks		Anticipated in about 44 months following first patient enrolled
Secondary	Gynecologic Cancer Intergroup (GCIG) CA125 response rate		Anticipated in about 44 months following first patient enrolled
Secondary	Clinical benefit rate at 24 weeks		Anticipated in about 44 months following first patient enrolled
Secondary	Duration of response (DOR)		Anticipated in about 44 months following first patient enrolled
Secondary	Time to response		Anticipated in about 44 months following first patient enrolled
Secondary	Overall survival		Anticipated in about 44 months following first patient enrolled
Secondary	Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, SAE, AE related to study drug, SAE related to study drug.		Anticipated in about 44 months following first patient enrolled
Secondary	Pharmacokinetics of talazoparib as assessed by trough plasma concentrations		Anticipated in about 44 months following first patient enrolled