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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    150
  • sponsor
    BeiGene
Updated on 25 June 2021
Investigator
Eric Hedrick, MD
Primary Contact
Peter MacCallum Cancer Centre (5.4 mi away) Contact
+27 other location

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.

Details
Condition Locally Advanced or Metastatic Solid Tumors
Treatment Temozolomide, BGB-290, pamiparib
Clinical Study IdentifierNCT03150810
SponsorBeiGene
Last Modified on25 June 2021

Eligibility

Yes No Not Sure

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
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
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-nave 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
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 nave patients with soft tissue sarcoma might be allowed if standard
of care therapy is not suitable or available

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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