Breast Cancer Clinical Trial

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

Summary

The primary objective of this study is 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Age ≥18 years old with advanced or metastatic stage solid tumors
Eastern Cooperative Oncology Group (ECOG) status ≤ 1 and measurable disease per RECIST V1.1 (except for participants in dose escalation and prostate cancer participants)
Additional inclusion criteria for dose expansion cohorts:

Participants with homologous recombination deficiency (HRD+) or known BRCA mutant Ovarian cancer

a. Previously received at least 1 line of platinum containing chemotherapy and No progression or recurrent disease in 6 months from last platinum containing regimen. Participants with HRD+ or known breast cancer susceptibility gene (BRCA) mutant Triple-Negative Breast Cancer

a. 0 - 1 prior platinum-containing regimen (any treatment setting) and received ≤ 3 prior regimens (advanced or metastatic setting).

Participants with HRD+ or known BRCA mutant Prostate cancer

Chemotherapy-naïve or previously received ≤2 taxane-based regimens.
May have pre-or post-treatment with a novel androgen receptor targeted agent. Participants Small cell lung and gastric cancer

a. Previously received ≤ 2 prior lines of therapy. Participants with HRD+ NSCLC, head and neck cancer, esophageal cancer and soft tissue sarcomas

Must have tumors with with HRD+ as centrally determined
Must have received at least 1 but not more than 3 prior lines of therapy.

Treatment naïve patients with soft tissue sarcoma might be allowed if standard of care therapy is not suitable or available.

Key Exclusion Criteria: All participants

Prior exposure to a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
Refractory to platinum-based therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

139

Study ID:

NCT03150810

Recruitment Status:

Completed

Sponsor:

BeiGene

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There are 22 Locations for this study

See Locations Near You

Mount Sinai - PRIME
New York New York, 10029, United States
Montefiore Medical Center PRIME
New York New York, 10461, United States
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville Tennessee, 37203, United States
Mary Crowley Cancer Research Centers
Dallas Texas, 75251, United States
University of Texas- MD Anderson Cancer Center
Houston Texas, 77030, United States
Saint Vincent's Hospital
Darlinghurst New South Wales, 2010, Australia
Icon Cancer Centre Wesley
Auchenflower Queensland, 4066, Australia
Icon Cancer Centre Chermside
Chermside Queensland, 4032, Australia
Icon Cancer Centre North Lakes
North Lakes Queensland, 4509, Australia
Icon Cancer Centre South Brisbane
South Brisbane Queensland, 4101, Australia
Icon Cancer Centre Southport
Southport Queensland, 4215, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Institut Catalia d'oncologia- l'Hospitalet
Barcelona , 08908, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
START Madrid-Fundación Jiménez Díaz
Madrid , 28040, Spain
START-Madrid
Madrid , 28050, Spain
Hospital Universitario Virgen de la Macarena
Sevilla , 41009, Spain
Hospital Clínico de Valencia
Valencia , 46010, Spain
Sarah Cannon Research Institute UK
London Greater London, W1G 6, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre
Newcastle Newcastle Upon Tyne, NE7 7, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow Strathclyde, G12 O, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

139

Study ID:

NCT03150810

Recruitment Status:

Completed

Sponsor:


BeiGene

How clear is this clinincal trial information?

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