CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 139 enrolled
Drug / intervention
Pamiparib +1 moredrug
Likely dose
Not stated in 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/NCT03150810
NCT03150810Phase 1Completed
CompareCT.gov

A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors

BeiGene·interventional·Posted May 12, 2017·Updated Dec 20, 2024

In Brief

A Phase 1 clinical trial evaluating Pamiparib and Temozolomide for Locally Advanced or Metastatic Solid Tumors. Completed, enrolled 139 participants across 22 sites in 4 countries.

Detailed Summary

The primary objective of this study was to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced or Metastatic Solid Tumors
CountriesAustralia, Spain, United Kingdom, United States
CollaboratorsMyriad Genetics, Inc.

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartJun 28, 2017
Primary CompletionMay 4, 2023
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9.1 years ago

Interventions

Pamiparibdrug

Administered by mouth as a capsule twice daily

Temozolomidedrug

TMZ at various doses administered by mouth as a capsule once daily.