Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
BeiGene
Study ID
NCT03905148
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lifirafenib — DRUG
    RAF Dimer Inhibitor
  • mirdametinib — DRUG
    MEK Inhibitor

Study Details

This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.

Key Dates

First listed
Apr 5, 2019
Start date
May 1, 2019
Status verified
Jan 2026
Primary completion
Oct 9, 2024
Completion
Oct 23, 2025

Study Design

Enrollment
91 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens.
    Combination doses of, Mirdametinib at once a day and lifirafenib at once a day And Mirdametinib at twice a day and lifirafenib at once a day
  • Experimental: Part B: Expansion
    Approximately 20 participants with NRAS mutated solid tumors will be enrolled

Primary Outcome Measure

Adverse Events and Serious Adverse Events [ Time Frame: Approximately 2 years from date of the participants enrollment ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California Los AngelesSanta MonicaCalifornia90404-
MD AndersonHoustonTexas77030-

Find similar trials in Santa Monica, CA

By research site
University of California Los Angeles· Santa Monica, CAMD Anderson· Houston, TX

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