Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments pf-02341066, pemetrexed, docetaxel
Phase phase 3
Targets ALK, c-MET, ROS1
Sponsor Pfizer
Start date September 2009
End date March 2012
Trial size 347 participants
Trial identifier NCT00932893, 2009-012595-27, A8081007

Summary

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
pf-02341066
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
(Active Comparator)
Investigator selection of either pemetrexed or docetaxel as the active comparator
pemetrexed
Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
docetaxel
Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

Primary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Randomization until death (up to 112 weeks)
Overall Survival Probability at Month 6 and Month 12
time frame: Month 6, 12
Percentage of Participants With Objective Response (OR)
time frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Percentage of Participants With Disease Control at Week 6
time frame: Week 6
Percentage of Participants With Disease Control at Week 12
time frame: Week 12
Duration of Response (DR)
time frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Time to Tumor Response (TTR)
time frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Pre-Dose Plasma Concentration (Ctrough) of Crizotinib
time frame: Pre-dose on Day 1 of Cycle 1, 2, 3, 5
Pre-Dose Plasma Concentration at Steady State (Ctrough, ss) of Crizotinib
time frame: Pre-dose on Day 15 of Cycle 1
Number of Participants With Categorical Maximum QTcF for Crizotinib
time frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2
Percentage of Participants With Echinoderm Microtubule Associated Protein-Like 4-Anaplastic Lymphoma Kinase (EML4-ALK) Fusion Variants
time frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)
Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins
time frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)
Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough
time frame: Baseline up to end of treatment (up to 112 weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
time frame: Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)
time frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)
time frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - histologically or cytologically proven diagnosis of non-small cell lung cancer - positive for the ALK fusion gene (test provided by a central laboratory) - must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug - tumors must be measurable Exclusion Criteria: - prior treatment with PF-02341066 - current treatment in another clinical trial

Additional Information

Official title Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Pfizer.