CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 347 enrolled
Drug / intervention
PF-02341066 +2 moredrug
Likely dose
PF-02341066 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00932893
NCT00932893Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted Jul 3, 2009·Updated Jan 2, 2017

In Brief

A Phase 3 clinical trial evaluating PF-02341066, Pemetrexed, and 1 other intervention for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 347 participants across 264 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesAustralia, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 3, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2012
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.0 years ago

Interventions

PF-02341066drug

PF-02341066, 250 mg BID will be administered orally on a continuous schedule

Pemetrexeddrug

Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle

Docetaxeldrug

Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle