NCT03150810

Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	Pamiparib	Administered by mouth as a capsule twice daily
DRUG	Temozolomide	TMZ at various doses administered by mouth as a capsule once daily.

Timeline

• Start date: 2017-06-28
• Primary completion: 2023-05-04
• Completion: 2023-05-04
• First posted: 2017-05-12
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

22 sites across 4 countries: United States, Australia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study