Trials / Completed
CompletedNCT01286987
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Talazoparib | Oral capsule with multiple dosage forms given once daily |
Timeline
- Start date
- 2011-01-03
- Primary completion
- 2015-03-31
- Completion
- 2017-01-30
- First posted
- 2011-02-01
- Last updated
- 2019-01-10
- Results posted
- 2019-01-10
Locations
15 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01286987. Inclusion in this directory is not an endorsement.