This trial is active, not recruiting.

Condition neoplasms malignant
Treatment crizotinib
Phase phase 1
Targets ALK, c-MET, ROS1
Sponsor Pfizer
Start date March 2011
End date December 2016
Trial size 44 participants
Trial identifier NCT01121588, 2010-022978-14, A8081013, PROFILE 1013


This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Masking open label
Primary purpose treatment
crizotinib PF-02341066
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities
time frame: 36 Months
Overall Response Rate
time frame: 36 months

Secondary Outcomes

Duration of Response
time frame: 36 months
Plasma concentrations of crizotinib
time frame: 30 Months
Overall Survival
time frame: 36 Months
Proportion of patients with each of the ALK genetic events
time frame: 36 Months
Progression-Free Survival (PFS)
time frame: 36 Months
Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available
time frame: 36 months

Eligibility Criteria

Male or female participants at least 15 years old.

Inclusion Criteria: - histologically or cytologically proven diagnosis of malignancy other than NSCLC - positive for translocation or inversion event involving the ALK gene locus - positive for ALK amplification events - positive for ALK activating point mutations Exclusion Criteria: - mutations of amplifications involving the c-Met gene but not the ALK gene - concurrent treatment on another therapeutic clinical trial - prior therapy specifically directed against ALK

Additional Information

Official title Phase 1b Open-label Study Of The Safety And Clinical Activity Of Crizotinib (Pf-02341066) In Tumors With Genetic Events Involving The Anaplastic Lymphoma Kinase (Alk ) Gene Locus
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pfizer.