Overview

This trial is active, not recruiting.

Conditions advanced or recurrent solid tumors, breast neoplasms, ovarian cancer, epithelial, ewing sarcoma, small cell lung carcinoma, prostate cancer, pancreas cancer
Treatment talazoparib
Phase phase 1
Target PARP
Sponsor Medivation, Inc.
Start date December 2010
End date March 2015
Trial size 74 participants
Trial identifier NCT01286987, PRP-001

Summary

This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
talazoparib BMN 673
Oral capsule with multiple dosage forms given once daily

Primary Outcomes

Measure
The primary outcome of this study is to determine the maximum tolerated dose (MTD) of daily oral talazoparib
time frame: Assessed after each visit until completion of Part 1 (Estimated duration is 12-18 months)

Secondary Outcomes

Measure
Number of participants with adverse events
time frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months)
Determine the pharmacokinetic (PK) profile of talazoparib
time frame: Assessed at each visit in cycle 1 - 5 (Estimated duration is 24 months)
Determine the Recommended Phase 2 Dose (RP2D) of oral daily talazoparib
time frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months)
Assess preliminary efficacy of talazoparib by Response Rate, based on RECIST (Response Evaluation Criteria In Solid Tumors)
time frame: Assessed approximately every 8 weeks (Estimated duration is 24-30 months)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor - Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE]. - 18 years of age or older. - Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer). - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. - Have adequate organ function - Able to take oral medications. - Willing and able to provide informed consent. - Sexually active patients must be willing to use an acceptable method of contraception. - Females of childbearing potential must have a negative serum pregnancy test at screening. - Willing and able to comply with all study procedures. Part 2 Dose Expansion Tumor Types: - Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease. - Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease. - Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC. - Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease. Exclusion Criteria: - Part 2 Expansion: Prior treatment with a PARP inhibitor. - Has history of central nervous system (CNS) metastasis. * Exception: In patients with SCLC, history of adequately treated brain metastasis who do not require corticosteroids for management of CNS symptoms. - Has had major surgery within 28 days before Cycle 1, Day 1. - Has active peptic ulcer disease. - Active gastrointestinal tract disease with malabsorption syndrome. - Pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.

Additional Information

Official title A Phase 1, First in Human, Single-arm, Open-label Study of Once a Day, Orally Administered Talazoparib in Patients With Advanced or Recurrent Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Medivation, Inc..