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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04672460
The ClinicalTrials.gov registry entry for NCT04672460 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Related
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