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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12614001176651 | Registry Identifier | The Australian New Zealand Clinical Trials Registry |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGB-283 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-283 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events in phase 1a | From first dose to within 28 days of last dose of BGB-283, within 1 years in average | |
| Objective response rate based on RECIST Version 1.1 in subjects with selected tumor types in phase 1b | From the first administration of the investigational product to the end of the study treatment, within 1 year in average |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) in phase 1a | During first 2 weeks | |
| Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a |
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Inclusion Criteria:
Provided written informed consent prior to enrollment.
Male or female and at least 18 years of age.
A life expectancy of at least 12 weeks.
Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available.
One of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Able to swallow and retain oral medication.
Adequate bone marrow, liver, and renal function:
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.
Subjects with treated brain metastasis are eligible to enter and participate in the study if they are neurologically stable.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayesh Desai, MD | Peter MacCallum Cancer Centre, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris Obrien Lifehouse | Camperdown | New South Wales | 2050 | Australia | ||
| North Coast Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32182156 | Result | 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. |
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Upon request, and subject to certain criteria, conditions, and exceptions, BeiGene will provide access to individual de-identified participant data from BeiGene-sponsored global interventional clinical studies conducted for medicines for indications that have been approved or in programmes that have been terminated. BeiGene will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data requests can be submitted to medicalinformation@beigene.com.
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| During first 2 weeks |
| Maximum plasma concentration (Cmax) in phase 1a | During first 2 weeks |
| Time to reach maximum plasma concentration (tmax) in phase 1a | During first 2 weeks |
| Terminal elimination half-life (t1/2) in phase 1a | During first 2 weeks |
| Tumor response in phase 1a | Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, within 1 year in average |
| Number of participants with adverse events in phase 1b | From first dose to within 28 days of last dose of BGB-283, within 1 year in average |
| Progression-free survival (PFS) | The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average |
| Macquarie |
| New South Wales |
| 2444 |
| Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Tasman Oncology Research Ltd | Southport Gold Coast | Queensland | 4216 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Cabrini Hospital Malvern | Malvern | Victoria | 3144 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Alfred Cancer Trials | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3052 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Dunedin Hospital | Dunedin | 9016 | New Zealand |
| Waikato Hospital | Hamilton Waikato | 3204 | New Zealand |
| Wellington Regional Hospital (Ccdhb) | Wellington | 6021 | New Zealand |
| ID | Term |
|---|---|
| C000609386 | BGB-283 |
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