CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 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 approved treatment options
  • ✓Age ≥18 years
  • ✓ECOG performance status ≤2
  • ✓Expected life expectancy ≥3 months
Key exclusion· 11
  • ✕Systemic anticancer therapy or investigational drug within 14 days or five half-lives prior to enrollment (whichever is longer)
  • ✕Unrecovered acute toxicities (>CTCAE grade 1) from previous anticancer therapy, except alopecia or lab abnormalities meeting eligibility criteria
  • ✕Major surgery within 28 days prior to enrollment
  • ✕Serious accompanying cardiac disorder

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

Search/NCT02997163
NCT02997163Phase 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 RENAL IMPAIRMENT

Pfizer·interventional·Posted Dec 19, 2016·Updated Jan 5, 2021

In Brief

A Phase 1 clinical trial evaluating Talazoparib for Advanced Solid Tumors. Completed, enrolled 34 participants across 10 sites in 2 countries.

Detailed Summary

This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumors and impaired renal function.

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 19, 2016
Enrollment StartFeb 21, 2017
Primary CompletionJan 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.5 years ago

Interventions

Talazoparibdrug

Daily oral doses of talazoparib 0.5 mg