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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 : April 22, 2020
Sponsor:
Collaborator:
Myriad Genetics, Inc.
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and temozolomide (TMZ) in participants with locally advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Tumors Drug: BGB-290 Drug: Temozolomide Phase 1 Phase 2

Detailed Description:
This is an open-label study of BGB‑290 and temozolomide (TMZ) with a dose escalation and dose expansion phase. Dose escalation will evaluate safety, tolerability, preliminary efficacy, and PK and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for the two drug combination. It is a modified 3+3 dose escalation scheme with a fixed dose of BGB‑290 in combination with escalating doses of TMZ. Dose expansion will evaluate the safety, PK profile and anti-tumor activity of BGB-290 and TMZ at a dose/schedule selected from the dose escalation phase. Five different solid malignancy types (n=100) will be evaluated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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 : July 12, 2017
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A (Dose Escalation)
Approximately 25 subjects to receive continuous BGB-290 and TMZ (Days 1 - 7 of 28 day cycle).
 Drug: BGB-290
BGB-290

Drug: Temozolomide
TMZ
Other Name: TMZ
Experimental: Arm B (Dose Escalation)
Approximately 25 subjects to receive continuous BGB-290 and continuous TMZ (28-day cycle).
 Drug: BGB-290
BGB-290

Drug: Temozolomide
TMZ
Other Name: TMZ
Experimental: Arm C (Dose Expansion)
Approximately 100 subjects to receive BGB-290 and TMZ.
 Drug: BGB-290
Dose/schedule selected based on dose escalation phase.

Drug: Temozolomide
Dose/schedule selected based on dose escalation phase.
Other Name: TMZ


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and nature of dose limiting toxicities (DLTs) as assessed by CTCAE. [ Time Frame: From first dose BGB-290 to 28 days post-dosing. ]
  2. Incidence, nature and severity of adverse events as assessed by CTCAE. [ Time Frame: From first dose BGB-290 to 30 days post-dosing.] ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) parameters (Cmax) of BGB-290 and TMZ. [ Time Frame: From first dose BGB-290 to 30 days post-dosing. ]
  2. Pharmacokinetic (PK) parameters (Tmax) of BGB-290 and TMZ. [ Time Frame: From first dose BGB-290 to 30 days post-dosing. ]
  3. Objective response rate (ORR) as assessed using RECIST. [ Time Frame: From first dose BGB-290 to first documentation of disease progression, assessed up to 5 years. ]
  4. Duration of response (DOR). [ Time Frame: From first dose BGB-290 to first documentation of disease progression, assessed up to 5 years ]
  5. Disease control rate (DCR) [ Time Frame: From first dose BGB-290 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 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 until date of death, assessed up to 5 years ]

Eligibility Criteria
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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 patients in dose escalation and prostate cancer patients)
  3. Additional inclusion criteria for dose expansion cohorts:

Patients 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. Patients 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).

Patients 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. Small cell lung and gastric cancer

a. Previously received ≤ 2 prior lines of therapy.

Key Exclusion Criteria: All patients

  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.

Contacts and Locations
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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: Claudia Andreu Vieyra, MD BeiGene
More Information
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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: April 22, 2020
Last Verified: April 2020
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
neoplasms
 temozolomide
BGB-290
antineoplastic agents
alkylating, alkylating agents,
Poly (ADP-ribose) polymerase inhibitors
enzyme inhibitors
Additional relevant MeSH terms:
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Neoplasms
Temozolomide
Antineoplastic Agents, Alkylating
 Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents