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
Public ClinicalTrials.gov record NCT04672460. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 1, OPEN LABEL, CROSSOVER STUDY TO ESTABLISH BIOEQUIVALENCE BETWEEN THE PROPOSED SOFT GEL TALAZOPARIB CAPSULE FORMULATION AND THE CURRENT TALAZOPARIB COMMERCIAL FORMULATION AND TO ESTIMATE THE FOOD EFFECT ON PHARMACOKINETICS OF THE PROPOSED TALAZOPARIB SOFT GEL CAPSULE FORMULATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04672460
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 73 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2020 (Actual)
- Primary completion
- Feb 4, 2022 (Actual)
- Completion
- Jul 22, 2022 (Actual)
- Last update posted
- Sep 25, 2024
2020 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 8
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Cancer Associates for Research and Excellence, Inc (cCARE) | Encinitas | California | 92024 | — |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| California Cancer Associates for Research and Excellence, Inc (cCARE) | San Marcos | California | 92069 | — |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | — |
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Smilow Cancer Hospital Phase 1 Unit | New Haven | Connecticut | 06511 | — |
| Florida Cancer Specialists | Lake Mary | Florida | 32746 | — |
| Alliance for Multispecialty Research, LLC | Kansas City | Missouri | 64114 | — |
| NYU Langone Hospital - Long Island Oncology | Mineola | New York | 11501 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | — |
| NYU Investigational Pharmacy | New York | New York | 10016 | — |
| NYU Langone Medical Center (Tisch Hospital) | New York | New York | 10016 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| West Chester Hospital | West Chester | Ohio | 45069 | — |
| UPCI Investigational Drug Service | Pittsburgh | Pennsylvania | 15232 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Upmc Shadyside | Pittsburgh | Pennsylvania | 15232 | — |
| Mary Crowley Cancer Research - Medical City Hospital | Dallas | Texas | 75230 | — |
| NEXT Oncology | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04672460, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04672460 live on ClinicalTrials.gov.