Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

Part of paid clinical trials in Santa Rosa, California.

Sponsor
Kura Oncology, Inc.
Study ID
NCT05693090
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Tipifarnib — DRUG
    Oral administration
  • Osimertinib — DRUG
    Oral administration

Study Details

This is a Phase 1a/b, multicenter, open-label, dose escalation (1a) and dose expansion (1b) study. The purpose of this study is to measure safety, tolerability, and preliminary efficacy with the combination of tipifarnib with osimertinib in patients with advanced/metastatic EGFR-mutated non-small cell lung cancer.

Key Dates

Start date
Feb 1, 2023
Status verified
Mar 2023
Primary completion
Jul 27, 2027
Completion
Jul 27, 2027

Study Design

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

Arms

  • Experimental: Escalation Cohort
    Adult participants with EGFR-mutated Non-Small Cell Lung Cancer
  • Experimental: Expansion Cohort
    Adult participants with EGFR-mutated Non-Small Cell Lung Cancer

Primary Outcome Measure

For Dose Escalation determine a safe and tolerable Phase 2 dose of tipifarnib when used in combination with osimertinib [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Providence Medical GroupSanta RosaCalifornia95403-
The Valley HospitalRidgewoodNew Jersey07450-

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