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COMPLETED 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

NCT04672460 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 73 participants
Start Date 2020-12-21
Est. Completion 2022-07-22
Phase Phase 1

Sponsor

Pfizer

769 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04672460 reports 20 study locations spanning 7 distinct geographic areas — top geographies include New York, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04672460?

The interventions under investigation include: TALZENNA capsule (DRUG), Talazoparib soft gel capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04672460?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial