An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 30, 2009
Last updated: February 5, 2016
Last verified: February 2016
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: PF-02341066
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2, Open-Label Single Arm Study Of The Efficacy And Safety Of PF-02341066 In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • 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 ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: 30 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 ]
  • 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 ]
  • Protein expression of identified biomarkers in serial tumor samples (when available) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Time to Tumor Response [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • QTc [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • genotypes of alleles possibly associated with adverse hepatic or renal drug reactions [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Enrollment: 1069
Study Start Date: January 2010
Study Completion Date: December 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-0231066 Drug: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
  • may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
  • Tumors can be measurable or non measurable

Exclusion Criteria:

  • prior treatment with PF-02341066
  • received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
  • current enrollment in another therapeutic clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00932451

  Show 271 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00932451     History of Changes
Other Study ID Numbers: A8081005  2009-012504-13 
Study First Received: June 30, 2009
Last Updated: February 5, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lung Neoplasms ALK gene Crizotinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 26, 2016