Solid TumorsPhase 1NCT02610361
Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors
A Phase 1 study testing BGB-283 in people with Solid Tumors, run by BeiGene at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BGB-283
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 20 Nov 2013to Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Able to swallow and retain oral medication.
- 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).
- Female subjects are eligible to enter and participate in the study if they are of:
- Non childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who
- Has had a hysterectomy,
- Has had a bilateral oophorectomy (ovariectomy),
- Has had a bilateral tubal ligation, or
- Is post menopausal (total cessation of menses for ≥ 1 year).
- 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:
- Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
- Any intrauterine device with a documented failure rate of less than 1% per year.
- 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.
Who cannot join
- Female subjects who are pregnant or lactating.
- Subjects receiving cancer therapy (chemotherapy or other systemic anti cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment.
- Any major surgery within 28 days prior to enrollment.
- Any radiotherapy within 14 days prior to enrollment, providing the subject has recovered from all toxicities to NCI-CTCAE ≤ Grade 1.
- Use of any investigational anti cancer drug within 28 days before the first investigational product administration.
- Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy, unless agreed by the sponsor.
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- History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- 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).
- Untreated leptomeningeal or brain metastasis. Subjects with previously treated brain metastasis that are asymptomatic, off steroids for longer than 28 days are permitted.
- 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.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- As a result of the medical interview, physical examination or screening investigations, the investigator considers the subject unfit for study.
- Is on medication listed in the protocol or requires any of these medications during treatment with BGB-283.
- Candidates for curative therapy.
- Unable or unwilling to comply with the required treatment.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Australia15 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Box Hill Hospital
Box Hill, Victoria, 3128
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Chris Obrien Lifehouse
Camperdown, New South Wales, 2050
Monash Health
Clayton, Victoria, 3168
Austin Health
Heidelberg, Victoria, 3084
North Coast Cancer Institute
Macquarie, New South Wales, 2444
Cabrini Hospital Malvern
Malvern, Victoria, 3144
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Alfred Cancer Trials
Melbourne, Victoria, 3004
Linear Clinical Research
Nedlands, Western Australia, 6009
Royal Melbourne Hospital
Parkville, Victoria, 3052
Prince of Wales Hospital
Randwick, New South Wales, 2031
Tasman Oncology Research Ltd
Southport Gold Coast, Queensland, 4216
Westmead Hospital
Westmead, New South Wales, 2145
New Zealand4 sites
Christchurch Hospital
Christchurch, 8011
Dunedin Hospital
Dunedin, 9016
Waikato Hospital
Hamilton Waikato, 3204
Wellington Regional Hospital (Ccdhb)
Wellington, 6021
About this study
Official title: 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
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.
- Conditions
- Solid Tumors
- Being tested
- BGB-283
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-283Drug
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
| Study group | Role | What they receive |
|---|---|---|
| BGB-283 | Experimental | Not described Receives: Drug: BGB-283 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events in phase 1a
Measured: 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
Measured: From the first administration of the investigational product to the end of the study treatment, within 1 year in average
Secondary outcomes (8)
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) in phase 1a
Measured: During first 2 weeks
Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a
Measured: During first 2 weeks
Maximum plasma concentration (Cmax) in phase 1a
Measured: During first 2 weeks
Time to reach maximum plasma concentration (tmax) in phase 1a
Measured: During first 2 weeks
Terminal elimination half-life (t1/2) in phase 1a
Measured: During first 2 weeks
Tumor response in phase 1a
Measured: 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
Measured: From first dose to within 28 days of last dose of BGB-283, within 1 year in average
Progression-free survival (PFS)
Measured: The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start20 Nov 2013
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jayesh Desai, MD, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610361
- Sponsor's protocol ID
- BGB-283-AU-001
- Other IDs
- ACTRN12614001176651
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2015
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 32182156
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02610361
- Acronym / sponsor ID
- BGB-283-AU-001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGB-283 | Experimental | Drug: BGB-283 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.
Key exclusion criteria (15 listed)
- Female subjects who are pregnant or lactating.
- Subjects receiving cancer therapy (chemotherapy or other systemic anti cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment.
- Any major surgery within 28 days prior to enrollment.
- Any radiotherapy within 14 days prior to enrollment, providing the subject has recovered from all toxicities to NCI-CTCAE ≤ Grade 1.
- Use of any investigational anti cancer drug within 28 days before the first investigational product administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-283In 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 | Drug | BGB-283 |
Primary outcome
Number of participants with adverse events in phase 1a
Time frame: 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
Time frame: From the first administration of the investigational product to the end of the study treatment, within 1 year in average
8 secondary outcomes
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) in phase 1a
Time frame: During first 2 weeks
Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a
Time frame: During first 2 weeks
Maximum plasma concentration (Cmax) in phase 1a
Time frame: During first 2 weeks
Time to reach maximum plasma concentration (tmax) in phase 1a
Time frame: During first 2 weeks
Terminal elimination half-life (t1/2) in phase 1a
Time frame: During first 2 weeks
Tumor response in phase 1a
Time frame: 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
Time frame: From first dose to within 28 days of last dose of BGB-283, within 1 year in average
Progression-free survival (PFS)
Time frame: The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Results publication: PubMed 32182156Desai 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.
- Individual participant dataSharing planned: Yes. 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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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayesh Desai, MD principal investigator
Peter MacCallum Cancer Centre, Australia
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-283 in people with Solid Tumors, run by BeiGene at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events in phase 1a (time frame: From first dose to within 28 days of last dose of BGB-283, within 1 years in average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.