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Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects 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 : July 19, 2019
Sponsor:
Collaborator:
Myriad Genetics, Inc.
Information provided by (Responsible Party):
BeiGene ( BeiGene USA, Inc. )

Brief Summary:
This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and temozolomide (TMZ) in subjects 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.

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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 : July 1, 2020
Estimated Study Completion Date : August 1, 2020


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




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 subject 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 ]


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

Inclusion Criteria: All subjects

  1. Age ≥18 years old.
  2. Confirmed malignancy at advanced or metastatic stage.
  3. ECOG status ≤ 1.
  4. Adequate bone marrow function.
  5. Adequate renal and hepatic function.
  6. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 90 days after last dosing.
  7. Must have measurable or evaluable disease per RECIST [Dose escalation phase only]

    Additional inclusion criteria 8 - 12 are specific to tumor types in dose expansion phase:

  8. Ovarian cancer

    1. Previously received at least 1 line of platinum containing chemotherapy.
    2. No progression or recurrent disease in 6 months from last platinum containing regimen.
  9. Triple-Negative Breast Cancer

    a. 0 - 1 prior platinum-containing regimen (any treatment setting) and received ≤ 3 prior regimens (advanced or metastatic setting).

  10. Prostate cancer

    1. Documented progressive disease.
    2. Chemotherapy-naïve or previously received ≤2 taxane-based regimens.
    3. May be pre-or post-treatment with a novel androgen receptor targeted agent.
    4. Completed in ≥ 2 weeks radiation or treatment with anti-androgen agents.
  11. Ovarian, breast and prostate cancer: If homologous recombinant deficiency (HRD) or BRCA status unknown, need pre-screening for eligibility.
  12. Small cell lung and gastric cancer: previously received ≤ 2 prior lines of therapy.

Exclusion Criteria: All subjects

  1. Prior exposure to a PARP inhibitor.
  2. Prior chemotherapy, biologic therapy, immunotherapy or investigational agents within 3 weeks prior to start of study treatment.
  3. Refractory to platinum-based therapy.
  4. Toxicity of ≥ Grade 2 from prior therapy.
  5. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  6. History of other active malignancies within 2 years with exception of (i) adequately treated in situ carcinoma of the cervix, (ii) non-melanoma skin cancer, or (iii) localized adequately treated cancer with curative intent or malignancy diagnosed > 2 years ago with no evidence of disease and no treatment ≤ 2 years prior to study treatment.
  7. Untreated leptomeningeal or brain metastasis.
  8. Active infection requiring systemic treatment.
  9. Known human immunodeficiency virus (HIV) or active viral hepatitis.
  10. Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or CVA ≤ 6 months prior to start of treatment.
  11. Active, clinically significant gastrointestinal disease.
  12. Use of any medications or food known to be strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong inducers.
  13. Pregnant or nursing females.

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: Claudia Andreu-Vieyra 1 (877) 828-5568 clinicaltrials@beigene.com
Contact: Rainer Brachmann, MD 1 (877) 828-5568 clinicaltrials@beigene.com

Locations
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United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Nehal Lakhani, MD, PhD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Haesong Park, MD         
United States, New York
Mount Sinai - PRIME Recruiting
New York, New York, United States, 10029
Principal Investigator: Matthew Galsky, MD         
Montefiore Medical Center PRIME Recruiting
New York, New York, United States, 10461
Principal Investigator: Sanjay Goel, MD         
United States, Tennessee
Sarah Cannon Research Institute (Tennessee Oncology) Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Melissa Johnson, MD         
United States, Texas
Mary Crowley Cancer Research Centers Recruiting
Dallas, Texas, United States, 75251
Principal Investigator: Minal Barve         
University of Texas- MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Siqing Fu         
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Principal Investigator: Lisa Horvath         
Saint Vincent's Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Principal Investigator: Anthony Joshua         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Principal Investigator: Linda Mileshkin         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Ana Oaknin         
Institut Catalia d'oncologia- l'Hospitalet Recruiting
Barcelona, Spain, 08908
Principal Investigator: Marta Gil         
START Madrid-Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Principal Investigator: Victor Moreno         
START-Madrid Recruiting
Madrid, Spain, 28050
Principal Investigator: Emiliano Calvo         
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Principal Investigator: Andres Manuel Cervantes         
United Kingdom
Sarah Cannon Research Institute UK Recruiting
London, Greater London, United Kingdom, W1G 6AD
Principal Investigator: Hendrik Arkenau         
Sir Bobby Robson Cancer Trials Research Centre Recruiting
Newcastle, Newcastle Upon Tyne, United Kingdom, NE7 7DN
Principal Investigator: Ruth Plummer         
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Strathclyde, United Kingdom, G12 OYN
Principal Investigator: Jeff Evans         
University College London Hospitals Recruiting
London, United Kingdom, WC1N 3BG
Principal Investigator: Rebecca Kristeliet         
Sponsors and Collaborators
BeiGene USA, Inc.
Myriad Genetics, Inc.

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Responsible Party: BeiGene USA, Inc.
ClinicalTrials.gov Identifier: NCT03150810     History of Changes
Other Study ID Numbers: BGB-290-103
2017-001553-14 ( EudraCT Number )
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by BeiGene ( BeiGene USA, Inc. ):
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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Temozolomide
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors