Overview

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 2017
Trial size 44 participants
Trial identifier NCT01121588, 2010-022978-14, A8081013, PROFILE 1013

Summary

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
Arm
(Experimental)
crizotinib PF-02341066
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule

Primary Outcomes

Measure
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

Measure
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 December 2016.
Information provided to ClinicalTrials.gov by Pfizer.
Location data was received from the National Cancer Institute and was last updated in December 2016.