You are here

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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 (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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02836028
Pfizer
Withdrawn
A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Ovarian Cancer HR+ HER2- Metastatic Breast Cancer
NCT03519178
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now