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NCT04672460 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 20
- Study locations
NCT04672460: Completed Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by Pfizer.
NCT04672460 is a Phase 1 study of Breast Cancer and Prostate Cancer that has completed, run by Pfizer. The registered enrollment target is 73 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04672460, a Phase 1 study of Breast Cancer and Prostate Cancer, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 20
- Study locations
Study Summary
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.
Primary Outcome
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Conditions Studied
Interventions
- DRUG TALZENNA capsule
- DRUG Talazoparib soft gel capsule
Study Locations (20)
New York
- NYU Langone Hospital - Long Island Oncology - Mineola
- NYU Langone Hospital - Long Island - Mineola
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York
- NYU Investigational Pharmacy - New York
- NYU Langone Medical Center (Tisch Hospital) - New York
- Montefiore Medical Center - The Bronx
California
- California Cancer Associates for Research and Excellence, Inc (cCARE) - Encinitas
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- California Cancer Associates for Research and Excellence, Inc (cCARE) - San Marcos
Connecticut
- Smilow Cancer Hospital at Yale New Haven - New Haven
- Yale-New Haven Hospital - New Haven
- Smilow Cancer Hospital Phase 1 Unit - New Haven
Ohio
- University of Cincinnati Medical Center - Cincinnati
- University Hospitals Cleveland Medical Center - Cleveland
- West Chester Hospital - West Chester
Pennsylvania
- UPCI Investigational Drug Service - Pittsburgh
- UPMC Hillman Cancer Center - Pittsburgh
Florida
- Florida Cancer Specialists - Lake Mary
Missouri
- Alliance for Multispecialty Research, LLC - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2022-07-22 |
| Phase | Phase 1 |
What the finished NCT04672460 record still lists
NCT04672460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 8 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which TALZENNA capsule is the first listed.
NCT04672460 names 20 study sites across 7 states, led by New York, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04672460 about?
NCT04672460 is a clinical study titled "A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors". This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions...
What is the current status of trial NCT04672460?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2020-12-21. Estimated completion is 2022-07-22.
What conditions does trial NCT04672460 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer.
What interventions are being tested in trial NCT04672460?
The interventions under investigation include: TALZENNA capsule (DRUG), Talazoparib soft gel capsule (DRUG).
Who is sponsoring clinical trial NCT04672460?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04672460 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04672460's enrollment target sits among peer trials
73 684th of 1224 higher than 541 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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