Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors
NCT ID: NCT02610361
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
131 participants
INTERVENTIONAL
2013-11-20
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BGB-283
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Male or female and at least 18 years of age.
3. A life expectancy of at least 12 weeks.
4. Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available.
5. One of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
7. Able to swallow and retain oral medication.
8. Adequate bone marrow, liver, and renal function:
* Hemoglobin \> 9 g/dL
* Absolute neutrophil count ≥ 1000/mm\^3
* Platelets ≥ 100,000/mm\^3
* Total bilirubin ≤1.5 times the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with known liver metastasis)
* Creatinine clearance ≥ 45 mL/min (calculated by the Cockcroft Gault formula).
9. Female subjects are eligible to enter and participate in the study if they are of:
a) Non childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who
i) Has had a hysterectomy,
ii) Has had a bilateral oophorectomy (ovariectomy),
iii) Has had a bilateral tubal ligation, or
iv) Is post menopausal (total cessation of menses for ≥ 1 year).
b) Childbearing potential, has a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 28 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:
i) Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
ii) Any intrauterine device with a documented failure rate of less than 1% per year.
iii) Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.
10. Subjects with treated brain metastasis are eligible to enter and participate in the study if they are neurologically stable.
Exclusion Criteria
2. Subjects receiving cancer therapy (chemotherapy or other systemic anti cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment.
3. Any major surgery within 28 days prior to enrollment.
4. Any radiotherapy within 14 days prior to enrollment, providing the subject has recovered from all toxicities to NCI-CTCAE ≤ Grade 1.
5. Use of any investigational anti cancer drug within 28 days before the first investigational product administration.
6. Unresolved toxicity \> Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy, unless agreed by the sponsor.
7. History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or to any component of BGB-283. (To date there are no known Food and Drug Administration \[FDA\] approved drugs chemically related to BGB-283).
9. Untreated leptomeningeal or brain metastasis. Subjects with previously treated brain metastasis that are asymptomatic, off steroids for longer than 28 days are permitted.
10. Any unstable, pre-existing major medical condition that in the opinion of the Investigator contra indicates the use of an investigational product, including active infection, known human immunodeficiency virus (HIV) positive subjects, or known Hepatitis B or C.
11. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
12. As a result of the medical interview, physical examination or screening investigations, the investigator considers the subject unfit for study.
13. Is on medication listed in the protocol or requires any of these medications during treatment with BGB-283.
14. Candidates for curative therapy.
15. Unable or unwilling to comply with the required treatment.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Jayesh Desai, MD
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Centre, Australia
Locations
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Chris Obrien Lifehouse
Camperdown, New South Wales, Australia
North Coast Cancer Institute
Macquarie, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Tasman Oncology Research Ltd
Southport Gold Coast, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Cancer Trials
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton Waikato, , New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, , New Zealand
Countries
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References
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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.
Other Identifiers
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ACTRN12614001176651
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-283-AU-001
Identifier Type: -
Identifier Source: org_study_id