An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene | Not Recruiting
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Carcinoma, Non-Small-Cell Lung
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT00932893
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : PF-02341066, Drug : Pemetrexed, Drug : Docetaxel

Study Arm Groups : PF-02341066, Pemetrexed or Docetaxel, Pemetrexed or Docetaxel

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression-Free Survival (PFS); 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 Outcome Measures
  • Overall Survival (OS); Randomization until death (up to 112 weeks); Overall Survival Probability at Month 6 and Month 12; Month 6, 12; Percentage of Participants With Objective Response (OR); 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; Week 6; Percentage of Participants With Disease Control at Week 12; Week 12; Duration of Response (DR); 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); 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; Pre-dose on Day 1 of Cycle 1, 2, 3, 5; Pre-Dose Plasma Concentration at Steady State (Ctrough, ss) of Crizotinib; Pre-dose on Day 15 of Cycle 1; Number of Participants With Categorical Maximum QTcF for Crizotinib; 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; 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; 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; 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); 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); 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); Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Guy's Hospital
London
England
SE1 9RT
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
Oxford Transplant Centre, Churchill Hospital
Oxford
Oxfordshire
OX3 7LJ
Research Site
London
SW3 6JJ
Southampton General Hospital
Southampton
England
SO16 6YD
London
NW3 2QG
Research Site
Sutton
Surrey
SM2 5PT
Nuffield Health Wessex Hospital
Eastleigh
SO53 2DW
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Australia, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
A8081007
Sponsor(s)
Pfizer
Key Dates

Recruitment Start Date

Sep 2009

Recruitment End Date

Mar 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

30 Jun 2009

Last Updated

24 Jul 2015