CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 73 enrolled
Drug / intervention
TALZENNA capsule +2 moredrug
Likely dose
TALZENNA capsule 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04672460
NCT04672460Phase 1Completed
CompareCT.gov

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

Pfizer·interventional·Posted Dec 17, 2020·Updated Sep 25, 2024

In Brief

A Phase 1 clinical trial evaluating TALZENNA capsule and Talazoparib soft gel capsule for Advanced Solid Tumors and 7 related conditions. Completed, enrolled 73 participants across 31 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors, Solid Tumors, Ovarian Cancer, Breast Cancer, Prostate Cancer, NSCLC, Pancreatic Cancer, Colorectal Cancer
CountriesAustralia, United States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartDec 21, 2020
Primary CompletionFeb 4, 2022
Study CompletionJul 22, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.5 years ago

Interventions

TALZENNA capsuledrug

Current commercial talazoparib formulation 1 mg once daily given under fasting condition

Talazoparib soft gel capsuledrug

Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition

Talazoparib soft gel capsuledrug

Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition