MedTrace Logo

Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

NCT01286987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2019-01-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Advanced or Recurrent Solid Tumors
  • Breast Neoplasms
  • Ovarian Cancer, Epithelial
  • Ewing Sarcoma
  • Small Cell Lung Carcinoma
  • Prostate Cancer
  • Pancreas Cancer

Interventions

DRUG

Talazoparib

Oral capsule with multiple dosage forms given once daily

Sponsors & Collaborators

  • Medivation, Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

  • Medical Director · Medivation, Inc.

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-03
Primary Completion
2015-03-31
Completion
2017-01-30

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286987 on ClinicalTrials.gov