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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT03150810•BeiGene

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years old with advanced or metastatic stage solid tumors
•2. Eastern Cooperative Oncology Group (ECOG) status ≤ 1
•3. Have disease either evaluable (dose-escalation cohort) or measurable (dose-escalation and -expansion cohorts) per RECIST V1.1, except for prostate cancer participants
•4. Agree to provide archival tumor tissue
•* Participants with homologous recombination deficiency (HRD+) or known BRCA mutant ovarian cancer Previously received at least one line of platinum-containing therapy in the advanced or metastatic setting and No progression or recurrent disease within 6 months from last platinum-containing regimen.
•* Participants with HRD+ or known BRCA mutant triple-negative breast cancer Up to one prior platinum-containing treatment in any treatment setting and up to 3 prior lines of therapy in the advanced or metastatic setting
•* Participants with HRD+ or known BRCA mutant prostate cancer Chemotherapy-naïve or previously received up to two taxane-based chemotherapy regimens, with documented prostate cancer progression
•* Participants with small cell lung cancer and gastric cancer, previously received ≤ 2 prior lines of therapy
•* Other HRD+ solid tumors of multiple indications

Exclusion Criteria

•1. Prior treatment with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
•2. Refractory to platinum-based therapy (dose-expansion cohort).

Locations (22)

Start Midwest

Grand Rapids, Michigan, United States

Washington University in St Louis

St Louis, Missouri, United States

Mount Sinai Prime

New York, New York, United States

Montefiore Medical Park At Eastchester Einstein Campus

The Bronx, New York, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Texas Oncology (Loop) Usor

Dallas, Texas, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

Saint Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Key Dates

Start Date

June 28, 2017

Primary Completion Date

May 4, 2023

Completion Date

May 4, 2023

Last Updated

December 20, 2024

Enrollment

139

ACTUAL participants

Conditions

Locally Advanced or Metastatic Solid Tumors

Interventions

Pamiparib

DRUG

Temozolomide

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

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