Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥18 years old with advanced or metastatic stage solid tumors
  2. Eastern Cooperative Oncology Group (ECOG) status ≤ 1 and measurable disease per RECIST V1.1 (except for participants in dose escalation and prostate cancer participants)
  3. 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

1. Chemotherapy-naïve or previously received ≤2 taxane-based regimens.

2. 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

1. Must have tumors with with HRD+ as centrally determined

2. 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.

Exclusion Criteria

All participants

1. Prior exposure to a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.

2. Refractory to platinum-based therapy.

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (Dose Escalation) TMZ Pulse Dosing
Participants receive continuous BGB-290 and escalating flat doses of 40mg, 80mg, 100mg, 120mg (as 20 mg capsules) daily administered orally up to the maximum tolerated dose (MTD) of TMZ on Days 1 - 7 of a 28-day cycle.
  • Drug: Pamiparib
    60 mg (20 mg capsules) administered orally twice a day
    Other names:
    • BGB-290
  • Drug: Temozolomide
    Doses of up to 120 mg (as 20 mg capsules) administered orally once daily (QD) as specified in the treatment arm
    Other names:
    • TMZ
    • temodar
Experimental
Arm B (Dose Escalation) TMZ Continuous Dosing
Participants receive continuous BGB-290 and escalating flat doses of 40mg, 80mg, 100mg, 120mg (as 20 mg capsules) daily administered orally up to the maximum tolerated dose (MTD) of TMZ on Days 1 - 28 of a 28-day cycle.
  • Drug: Pamiparib
    60 mg (20 mg capsules) administered orally twice a day
    Other names:
    • BGB-290
  • Drug: Temozolomide
    Doses of up to 120 mg (as 20 mg capsules) administered orally once daily (QD) as specified in the treatment arm
    Other names:
    • TMZ
    • temodar
Experimental
Dose Expansion, 6 cohorts
Participants receive continuous BGB-290 and TMZ at the recommended phase 2 dose (RP2D) and schedule in 28 day cycles
  • Drug: Pamiparib
    60 mg (20 mg capsules) administered orally twice a day
    Other names:
    • BGB-290
  • Drug: Temozolomide
    Doses of up to 120 mg (as 20 mg capsules) administered orally once daily (QD) as specified in the treatment arm
    Other names:
    • TMZ
    • temodar

Recruiting Locations

Montefiore Medical Center PRIME
New York, New York 10461

More Details

Status
Recruiting
Sponsor
BeiGene

Study Contact

BeiGene
1 (877) 828-5568
clinicaltrials@beigene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.