CompletedPhase 1NCT03150810

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

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.

Checked against the public recordLast updated Dec 20, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations22
SponsorBeiGene
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
BeiGene
Interventions being studied
Drug: Pamiparib; Drug: Temozolomide
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key 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 5. Additional inclusion criteria for dose expansion cohorts: * 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 Key Exclusion Criteria: All participants 1. Prior treatment with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor. 2. Refractory to platinum-based therapy (dose-expansion cohort). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Start MidwestGrand Rapids, Michigan
  • Washington University in St LouisSt Louis, Missouri
  • Mount Sinai PrimeNew York, New York
  • Montefiore Medical Park At Eastchester Einstein CampusThe Bronx, New York
  • Sarah Cannon Cancer CenterNashville, Tennessee
  • Texas Oncology (Loop) UsorDallas, Texas
  • The University of Texas Md Anderson Cancer CenterHouston, Texas
  • Chris Obrien LifehouseCamperdown, New South Wales
  • Saint Vincents Hospital SydneyDarlinghurst, New South Wales
  • Icon Cancer Centre South BrisbaneSouth Brisbane, Queensland
  • Peter Maccallum Cancer CentreMelbourne, Victoria
  • Hospital Universitario Vall DhebronBarcelona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 20, 2024. Always confirm current availability with the study team.

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