Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments ro5424802
Phase phase 2
Target ALK
Sponsor Hoffmann-La Roche
Start date September 2013
End date December 2015
Trial size 133 participants
Trial identifier NCT01871805, NP28761

Summary

This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of CH5424802/RO5424802 in patients with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of patients will receive escalating doses of CH5424802/RO5424802 orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose (600 mg) daily in two oral doses.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ro5424802 CH5424802
multiple escalating doses given orally twice daily
(Experimental)
ro5424802 CH5424802
Recommended Phase II dose (600 mg) given orally twice daily

Primary Outcomes

Measure
Phase I: Dose-limiting toxicity
time frame: approximately 2.5 years
Phase II: Objective response rate (ORR) evaluated by an independent review committee (IRC) using RECIST v. 1.1 criteria
time frame: approximately 2.5 years

Secondary Outcomes

Measure
Quality of life: EORTC QLQ-C30/QLQ-LC13 questionnaires
time frame: approximately 2.5 years
Phase II: CNS progression rate (CPR) evaluated by IRC according to RECIST v. 1.1 and RANO criteria
time frame: approximately 2.5 years
Pharmacokinetics (Phase I): Area under the concentration-time curve (AUC)
time frame: Pre-dose and post-dose up to Day 15 Cycle 1, pre- and post-dose Cycles 2 and 4
Pharmacokinetics (Phase II): Trough concentrations (Ctrough)
time frame: Pre- and post-dose Day 1 of Cycles 1, 2 and 4
Safety: Incidence of adverse events
time frame: approximately 2.5 years
Phase I: Tumor response
time frame: approximately 2.5 years
Phase II: ORR evaluated by investigator assessment using RECIST v. 1.1 criteria
time frame: approximately 2.5 years
Phase II: Disease control rate evaluated by IRC and investigator assessment
time frame: approximately 2.5 years
Phase II: Progression-free survival evaluated by IRC and investigator assessment
time frame: approximately 2.5 years
Phase II: Overall survival
time frame: approximately 2.5 years
Phase II: Duration of response evaluated by IRC and investigator assessment
time frame: approximately 2.5 years
Phase II: CNS objective response rate (CORR) evaluated by IRC according to RECIST v. 1.1 and RANO criteria
time frame: approximately 2.5 years
Phase II: CNS duration of response (CDOR) evaluated by IRC according to RECIST v. 1.1 and RANO criteria
time frame: approximately 2.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic non-small cell lung cancer (NSCLC) - ALK-rearrangement confirmed by FDA approved test - NSCLC that has failed crizotinib treatment - Measurable disease as defined by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status

Additional Information

Official title A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.
Location data was received from the National Cancer Institute and was last updated in May 2016.