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 : December 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Locally Advanced or Metastatic Solid Tumors | Drug: BGB-290 Drug: Temozolomide | Phase 1 Phase 2 |
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).
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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).
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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.
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Drug: BGB-290
Dose/schedule selected based on dose escalation phase. Drug: Temozolomide Dose/schedule selected based on dose escalation phase.
Other Name: TMZ |
- Incidence and nature of dose limiting toxicities (DLTs) as assessed by CTCAE. [ Time Frame: From first dose BGB-290 to 28 days post-dosing. ]
- Incidence, nature and severity of adverse events as assessed by CTCAE. [ Time Frame: From first dose BGB-290 to 30 days post-dosing.] ]
- Pharmacokinetic (PK) parameters (Cmax) of BGB-290 and TMZ. [ Time Frame: From first dose BGB-290 to 30 days post-dosing. ]
- Pharmacokinetic (PK) parameters (Tmax) of BGB-290 and TMZ. [ Time Frame: From first dose BGB-290 to 30 days post-dosing. ]
- 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. ]
- Duration of response (DOR). [ Time Frame: From first dose BGB-290 to first documentation of disease progression, assessed up to 5 years ]
- 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 ]
- 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 ]
- Overall survival (OS) [ Time Frame: From first dose BGB-290 until date of death, assessed up to 5 years ]

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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 |
Inclusion Criteria: All subjects
- Age ≥18 years old.
- Confirmed malignancy at advanced or metastatic stage.
- ECOG status ≤ 1.
- Adequate bone marrow function.
- Adequate renal and hepatic function.
- 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.
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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:
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Ovarian cancer
- Previously received at least 1 line of platinum containing chemotherapy.
- No progression or recurrent disease in 6 months from last platinum containing regimen.
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Triple-Negative Breast Cancer
a. 0 - 1 prior platinum-containing regimen (any treatment setting) and received ≤ 3 prior regimens (advanced or metastatic setting).
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Prostate cancer
- Documented progressive disease.
- Chemotherapy-naïve or previously received ≤2 taxane-based regimens.
- May be pre-or post-treatment with a novel androgen receptor targeted agent.
- Completed in ≥ 2 weeks radiation or treatment with anti-androgen agents.
- Ovarian, breast and prostate cancer: If homologous recombinant deficiency (HRD) or BRCA status unknown, need pre-screening for eligibility.
- Small cell lung and gastric cancer: previously received ≤ 2 prior lines of therapy.
Exclusion Criteria: All subjects
- Prior exposure to a PARP inhibitor.
- Prior chemotherapy, biologic therapy, immunotherapy or investigational agents within 3 weeks prior to start of study treatment.
- Refractory to platinum-based therapy.
- Toxicity of ≥ Grade 2 from prior therapy.
- Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
- 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.
- Untreated leptomeningeal or brain metastasis.
- Active infection requiring systemic treatment.
- Known human immunodeficiency virus (HIV) or active viral hepatitis.
- Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or CVA ≤ 6 months prior to start of treatment.
- Active, clinically significant gastrointestinal disease.
- Use of any medications or food known to be strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong inducers.
- Pregnant or nursing females.

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
Contact: Claudia Andreu-Vieyra | 1 (877) 828-5568 | clinicaltrials@beigene.com | |
Contact: Rainer Brachmann, MD | 1 (877) 828-5568 | clinicaltrials@beigene.com |
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Saint Vincent's Hospital | Recruiting |
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Melbourne, Victoria, Australia, 3000 | |
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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 |
Responsible Party: | BeiGene USA, Inc. |
ClinicalTrials.gov Identifier: | NCT03150810 History of Changes |
Other Study ID Numbers: |
BGB-290-103 |
First Posted: | May 12, 2017 Key Record Dates |
Last Update Posted: | December 19, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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:
Temozolomide Dacarbazine Poly(ADP-ribose) Polymerase Inhibitors Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |