Description:
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.
Title
- Brief Title: 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
- Official Title: A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
BGB-290-103
- SECONDARY ID:
2017-001553-14
- NCT ID:
NCT03150810
Conditions
- Locally Advanced or Metastatic Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
Pamiparib | BGB-290 | Arm A (Dose Escalation) TMZ Pulse Dosing |
Temozolomide | TMZ, temodar | Arm A (Dose Escalation) TMZ Pulse Dosing |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A (Dose Escalation) TMZ Pulse Dosing | Experimental | 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. | |
Arm B (Dose Escalation) TMZ Continuous Dosing | Experimental | 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. | |
Dose Expansion, 6 cohorts | Experimental | Participants receive continuous BGB-290 and TMZ at the recommended phase 2 dose (RP2D) and schedule in 28 day cycles | |
Eligibility Criteria
Key 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.
Key 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.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence and nature of dose limiting toxicities (DLTs) as assessed by CTCAE. |
Time Frame: | From first dose BGB-290 and TMZ to 28 days post-dosing |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | maximum observed plasma concentration (Cmax) of BGB-290 and TMZ. |
Time Frame: | From first dose BGB-290 and TMZ to 30 days post-dosing |
Safety Issue: | |
Description: | |
Measure: | lowest concentration reached before the next dose administered (Ctrough) of BGB-290 and TMZ. |
Time Frame: | From first dose BGB-290 and TMZ to 30 days post-dosing |
Safety Issue: | |
Description: | |
Measure: | time to reach maximum (peak) plasma concentration (Tmax) of BGB-290 and TMZ. |
Time Frame: | From first dose BGB-290 and TMZ to 30 days post-dosing |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR). |
Time Frame: | From first dose BGB-290 and TMZ to first documentation of disease progression, assessed up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (DCR) |
Time Frame: | From first dose BGB-290 and TMZ to first documentation of disease progression while participant is alive, assessed to up 5 years |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) |
Time Frame: | From first dose BGB-290 and TMZ to first documentation of disease progression or death, whichever is first, assessed up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | From first dose BGB-290 and TMZ until date of death, assessed up to 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | BeiGene |
Trial Keywords
- Ovarian cancer
- Triple negative breast cancer
- Small cell lung cancer
- Prostate cancer,
- Gastric cancer
- temozolomide
- BGB-290
- antineoplastic agents
- alkylating, alkylating agents,
- Poly (ADP-ribose) polymerase inhibitors
- enzyme inhibitors
- Head and neck cancer
- Esophageal cancer
- Soft tissue sarcoma
- Non small cell lung cancer
- pamiparib
Last Updated
June 16, 2021