CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
Talazoparibdrug
Likely dose
Talazoparib 0.5 mg daily orallyAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options
  • ✓Age ≥18 years
  • ✓ECOG performance status ≤2
  • ✓Expected life expectancy ≥3 months
Key exclusion· 12
  • ✕Systemic anticancer therapy or investigational drug within 14 days or 5 half-lives (whichever longer)
  • ✕Not recovered from acute toxicities of prior therapy (CTCAE grade >1, except alopecia)
  • ✕Major surgery within 28 days prior to enrollment
  • ✕Serious cardiac disorder

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

Search/NCT02997176
NCT02997176Phase 1Completed
CompareCT.gov

A PHASE I OPEN-LABEL PHARMACOKINETICS AND SAFETY STUDY OF TALAZOPARIB (MDV3800) IN PATIENTS WITH ADVANCED SOLID TUMORS AND NORMAL OR VARYING DEGREES OF HEPATIC IMPAIRMENT

Pfizer·interventional·Posted Dec 19, 2016·Updated Feb 25, 2021

In Brief

A Phase 1 clinical trial evaluating Talazoparib for Advanced Solid Tumors. Completed, enrolled 38 participants across 11 sites.

Detailed Summary

This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesUnited States
CollaboratorsMedivation, Inc.

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 19, 2016
Enrollment StartSep 30, 2016
Primary CompletionFeb 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.5 years ago

Interventions

Talazoparibdrug

Daily oral doses of talazoparib 0.5 mg