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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932893
First received: June 30, 2009
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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 lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
 Drug: PF-02341066
Drug: Pemetrexed
Drug: Docetaxel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Non-Small Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) of PF-02341066 vs Pemetrexed or Docetaxel [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Patient reported symptoms of lung cancer and health-related quality of life [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Type, incidence, severity, seriousness and relationship to study medication of adverse events and laboratory test abnormalities [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of PF-02341066 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Types of EML4-ALK fusion variants and ALK gene expression [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Plasma concentrations of pharmacodynamic biomarkers [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • QTc [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Time to Tumor Response [ Time Frame: 23 months ] [ Designated as safety issue: No ]

Enrollment: 347
Study Start Date: September 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-02341066 Drug: PF-02341066
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
Active Comparator: Pemetrexed or Docetaxel
Investigator selection of either pemetrexed or docetaxel as the active comparator
 Drug: Pemetrexed
Pemetrexed, 500 mg/m2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
Drug: Docetaxel
Docetaxel, 75 mg/m2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932893

  Show 237 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00932893     History of Changes
Other Study ID Numbers: A8081007
Study First Received: June 30, 2009
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lung Neoplasms ALK gene crizotinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Lymphoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 23, 2013