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Trial record 1 of 1 for:    NCT03905148.
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Study of the Safety and Pharmacokinetics of BGB-283 and PD-0325901 in Patients With Advanced or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905148
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborator:
SpringWorks Therapeutics, Inc.
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 5, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • Adverse Events and Serious Adverse Events [ Time Frame: Approximately 2 years from date of the patient enrollment ]
    Incidence and severity of AEs and SAEs and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
  • The incidence of DLT events and treatment-emergent AEs (TEAEs) [ Time Frame: Approximately 2 years from date of the patient enrollment ]
  • Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in subjects with selected tumor types [ Time Frame: Approximately 2 years from date of the patient enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 and PD-0325901 in Patients With Advanced or Refractory Solid Tumors
Official Title  ICMJE A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors
Brief Summary This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 combination in patients with tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Part A will consist of dose escalation and dose-finding components to establish the max tolerated dose and/or recommended Phase 2 dose Part B will investigate efficacy and further evaluate the PK, safety, and tolerability of the combination of PD-0325901 and BGB-283 (lifirafenib).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE
  • Drug: BGB-283 (lifirafenib)
    RAF Dimer Inhibitor
  • Drug: PD-0325901
    MEK Inhibitor
Study Arms  ICMJE
  • Experimental: Part A: Dose Level 1
    PD-0325901 at 2 mg once a day and BGB-283 (lifirafenib) at 15 mg once a day
    Interventions:
    • Drug: BGB-283 (lifirafenib)
    • Drug: PD-0325901
  • Experimental: Part A: Dose Level 2
    PD-0325901 at 2 mg once a day and BGB-283 (lifirafenib) at 20 mg once a day
    Interventions:
    • Drug: BGB-283 (lifirafenib)
    • Drug: PD-0325901
  • Experimental: Part A: Dose Level 3
    PD-0325901 at 4 mg once a day and BGB-283 (lifirafenib) at 20 mg once a day
    Interventions:
    • Drug: BGB-283 (lifirafenib)
    • Drug: PD-0325901
  • Experimental: Part A: Dose Level 4
    PD-0325901 at 6 or 8 mg once a day and BGB-283 (lifirafenib) at 20 or 25 mg once a day depending on the safety and tolerability observed at Levels 1, 2, and 3
    Interventions:
    • Drug: BGB-283 (lifirafenib)
    • Drug: PD-0325901
  • Experimental: Part B: Group 1
    Non-small cell lung cancer with confirmed K-RAS mutations, approximately 15 patients
    Interventions:
    • Drug: BGB-283 (lifirafenib)
    • Drug: PD-0325901
  • Experimental: Part B: Group 2
    Endometrial cancer with confirmed K-RAS mutations, approximately 15 patients
    Interventions:
    • Drug: BGB-283 (lifirafenib)
    • Drug: PD-0325901
  • Experimental: Part B: Group 3
    Tumor type of interest based on preliminary anti-tumor clinical activities observed in Part A, approximately 15 patients
    Interventions:
    • Drug: BGB-283 (lifirafenib)
    • Drug: PD-0325901
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Able to provide informed consent
  2. Age 18 on day of signing informed consent form (ICF) or of the legal age of consent in the jurisdiction in which the study is taking place
  3. Advanced or metastatic, unresectable tumors who have experienced disease progression

    • Part A: NSCLC, CRC, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, and other)
    • Part B: Group 1: NSCLC, Group 2: endometrial cancer, Group 3: Tumor types of interest based on preliminary anti-tumor activities observed in Part A
  4. Must have archival tumor tissue or agree to tumor biopsy
  5. Measureable disease per RECIST 1.1
  6. Eastern Cooperative Oncology Group performance status of greater than 1
  7. Life expectancy is greater than 12 weeks at the of signing ICF.
  8. Adequate organ function and no transfusion within 14 days of first dose.
  9. Females are of non-child bearing potential or willing to use contraception.
  10. Males vasectomized or agree to use contraception.

Exclusion Criteria:

  1. Central Nervous System metastasis
  2. Any retinal pathology considered to be a risk factor for central serous retinopathy
  3. History of glaucoma
  4. Active parathyroid disorder or history of malignancy associated hypercalcemia
  5. Clinically significant cardiac disease within the past 6 months of signing ICF.
  6. LVEF less than 50%
  7. Abnormal QT interval at Screening
  8. Severe uncontrolled systemic disease
  9. HIV
  10. Clinically significant active or known history of liver disease. (Hepatitis B and Hepatitis C)
  11. Hemorrhage or bleeding event at NCI-CTCAE v4.03 Grade 3 or higher within 28 days of first dose.
  12. Increased serum calcium
  13. Inability to swallow oral medications
  14. Ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks. No immunotherapy,biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
  15. Concomitant systemic or glucocorticoid therapy
  16. Concomitant vitamin D
  17. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
  18. Concomitant medicines that are strong CYP3A inhibitors
  19. History of significant toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these drugs
  20. Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1 (877) 828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03905148
Other Study ID Numbers  ICMJE BGB-283/PD-0325901-AU-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE SpringWorks Therapeutics, Inc.
Investigators  ICMJE
Study Director: Margaret Singh, Pharm.D. BeiGene
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