Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors

NCT02610361 | Completed Phase 1

• 2 other identifiers: BGB-283-AU-001ACTRN12614001176651
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 19

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

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

  During first 2 weeks

• Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a

  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

Study Arms (1)

BGB-283

EXPERIMENTAL

Drug: BGB-283

Interventions

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

BGB-283

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (19)

Chris Obrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

North Coast Cancer Institute

Macquarie, New South Wales, 2444, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Tasman Oncology Research Ltd

Southport Gold Coast, Queensland, 4216, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Alfred Cancer Trials

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton Waikato, 3204, New Zealand

Location

Wellington Regional Hospital (Ccdhb)

Wellington, 6021, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 32182156 RESULT

MeSH Terms

Interventions

BGB-283

Study Officials

• Jayesh Desai, MD

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: November 20, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

AU (15); NZ (4)