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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

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ClinicalTrials.gov Identifier: NCT03150810
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : February 25, 2021
Sponsor:
Collaborator:
Myriad Genetics, Inc.
Information provided by (Responsible Party):
BeiGene

Brief 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.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Tumors Drug: Pamiparib Drug: Temozolomide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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 ]
  2. Number of participants experiencing Adverse Events (AEs) [ Time Frame: From first dose BGB-290 and TMZ to 30 days post-dosing ]
  3. Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: From first dose BGB-290 and TMZ to 30 days post-dosing ]
  4. Objective Response Rate (ORR) [ Time Frame: From first dose BGB-290 and TMZ to first documentation of disease progression, assessed up to 5 years ]

Secondary Outcome Measures :
  1. maximum observed plasma concentration (Cmax) of BGB-290 and TMZ. [ Time Frame: From first dose BGB-290 and TMZ to 30 days post-dosing ]
  2. 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 ]
  3. 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 ]
  4. Duration of response (DOR). [ Time Frame: From first dose BGB-290 and TMZ to first documentation of disease progression, assessed up to 5 years ]
  5. 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 ]
  6. 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 ]
  7. Overall survival (OS) [ Time Frame: From first dose BGB-290 and TMZ until date of death, assessed up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150810


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

Locations
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Sponsors and Collaborators
BeiGene
Myriad Genetics, Inc.
Investigators
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Study Director: Maggie Zhang BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03150810    
Other Study ID Numbers: BGB-290-103
2017-001553-14 ( EudraCT Number )
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
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
Additional relevant MeSH terms:
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Neoplasms
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents