Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Davis, California.

Sponsor
University of California, San Francisco
Study ID
NCT03087448
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ceritinib — DRUG
    ALK tyrosine inhibitor, 300 mg - 450 mg PO daily. Phase I dose escalation: 1. Ceritinib 300mg 2. Ceritinib 450mg 3. Ceritinib 450mg The Phase II doses will be determined by Phase I dose escalation study
  • Trametinib — DRUG
    MEK kinase inhibitor, 1.5 mg - 2.0 mg PO daily. Phase I dose escalation: 1. Trametinib 1.5mg 2. Trametinib 1.5mg 3. Trametinib 2.0mg The Phase II doses will be determined by Phase I dose escalation study

Study Details

This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK or ROS-1 rearranged NSCLC. The Phase II portion will investigate the clinical efficiency of the combination of ceritinib and trametinib in 3 single arm cohorts: ALKi (ALK inhibitor) naïve patients; post-crizotinib progressed disease (PD) patients; and PD second line ALK tyrosine kinase inhibitor (TKI) patients.

Key Dates

Start date
Sep 9, 2017
Status verified
Dec 2022
Primary completion
Apr 30, 2022
Completion
Apr 30, 2022

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ceritinib + Trametinib
    PHASE 1 Standard 3+3 dose escalation starting at dose level 1. Patients with ALK-rearranged, or ROS-1 rearranged NSCLC. 6-18 patients will be enrolled. Ceritinib dose: 300-450mg orally, once daily over 28 day cycles. Trametinib dose: 1.5mg-2.0mg orally, once daily over 28 day cycles. PHASE II The study was terminated before Phase II was initiated. The study did not open Phase II for enrollment.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to 12 weeks. ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, DavisDavisCalifornia95616-
University of California, San FranciscoSan FranciscoCalifornia94143-

Find similar trials in Davis, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California, Davis· Davis, CAUniversity of California, San Francisco· San Francisco, CA

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