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NCT01286987 · ClinicalTrials.gov registry record · Phase 1
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 113
- Enrollment target
NCT01286987: Completed Phase 1 study, sponsored by Pfizer.
NCT01286987 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 113 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01286987, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 113 participants
- Enrollment target
Study 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.
Primary Outcome
Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter \[mm\] on the case report form \[CRF\]) and the reduction of the shortest diame
Interventions
- DRUG Talazoparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2011-01-03 |
| Est. Completion | 2017-01-30 |
| Phase | Phase 1 |
What the finished NCT01286987 record still lists
NCT01286987 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 1 intervention - of which Talazoparib is the first listed.
NCT01286987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01286987 about?
NCT01286987 is a clinical study titled "Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors". 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 d...
What is the current status of trial NCT01286987?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 113 participants. The study started on 2011-01-03. Estimated completion is 2017-01-30.
What interventions are being tested in trial NCT01286987?
The interventions under investigation include: Talazoparib (DRUG).
Who is sponsoring clinical trial NCT01286987?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01286987's enrollment target sits among peer trials
113 508th of 2000 higher than 1,493 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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