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

NCT03087448 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-12-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ceritinib

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

DRUG

Trametinib

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

Sponsors & Collaborators

Principal Investigators

  • Collin Blakely, MD, PhD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-09
Primary Completion
2022-04-30
Completion
2022-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087448 on ClinicalTrials.gov