Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors
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ClinicalTrials.gov Identifier: NCT02610361 |
Recruitment Status :
Completed
First Posted : November 20, 2015
Last Update Posted : March 25, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | November 18, 2015 | ||||||||
First Posted Date ICMJE | November 20, 2015 | ||||||||
Last Update Posted Date | March 25, 2020 | ||||||||
Actual Study Start Date ICMJE | November 20, 2013 | ||||||||
Actual Primary Completion Date | October 2017 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Number of participants with adverse events [ Time Frame: From first dose to within 28 days of last dose of BGB-283 ] | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors | ||||||||
Official Title ICMJE | A Phase 1A/1B, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Preliminary Antitumor Activities of the B RAF Inhibitor BGB 283 in Subjects With Solid Tumors | ||||||||
Brief Summary | This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-283 in patients with solid tumours. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumors | ||||||||
Intervention ICMJE | Drug: BGB-283
In the dose escalation part(phase 1a): the dose levels will be escalated following a modified 3+3 dose escalation scheme. In dose expansion phase(Phase 1b): Patients will be assigned to different groups based on their tumor types |
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Study Arms ICMJE | Experimental: BGB-283
Intervention: Drug: BGB-283
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Publications * | Desai J, Gan H, Barrow C, Jameson M, Atkinson V, Haydon A, Millward M, Begbie S, Brown M, Markman B, Patterson W, Hill A, Horvath L, Nagrial A, Richardson G, Jackson C, Friedlander M, Parente P, Tran B, Wang L, Chen Y, Tang Z, Huang W, Wu J, Zeng D, Luo L, Solomon B. Phase I, Open-Label, Dose-Escalation/Dose-Expansion Study of Lifirafenib (BGB-283), an RAF Family Kinase Inhibitor, in Patients With Solid Tumors. J Clin Oncol. 2020 Jul 1;38(19):2140-2150. doi: 10.1200/JCO.19.02654. Epub 2020 Mar 17. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
131 | ||||||||
Original Estimated Enrollment ICMJE |
230 | ||||||||
Actual Study Completion Date ICMJE | October 2017 | ||||||||
Actual Primary Completion Date | October 2017 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | Australia, New Zealand | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02610361 | ||||||||
Other Study ID Numbers ICMJE | BGB-283-AU-001 ACTRN12614001176651 ( Registry Identifier: The Australian New Zealand Clinical Trials Registry ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | BeiGene | ||||||||
Study Sponsor ICMJE | BeiGene | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | BeiGene | ||||||||
Verification Date | September 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |