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.
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.
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There are 22 Locations for this study
New York New York, 10029, United States
New York New York, 10461, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75251, United States
Houston Texas, 77030, United States
Darlinghurst New South Wales, 2010, Australia
Auchenflower Queensland, 4066, Australia
Chermside Queensland, 4032, Australia
North Lakes Queensland, 4509, Australia
South Brisbane Queensland, 4101, Australia
Southport Queensland, 4215, Australia
Melbourne Victoria, 3000, Australia
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
London Greater London, W1G 6, United Kingdom
Newcastle Newcastle Upon Tyne, NE7 7, United Kingdom
Glasgow Strathclyde, G12 O, United Kingdom
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