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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

NCT03150810 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2024-12-20

Study results available
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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

DRUG

Pamiparib

Administered by mouth as a capsule twice daily

DRUG

Temozolomide

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

Sponsors & Collaborators

  • Myriad Genetics, Inc.

    collaborator INDUSTRY

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2023-05-04
Completion
2023-05-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150810 on ClinicalTrials.gov