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 - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00932451

Purpose

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 II

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 Non-Small Cell Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Lung Cancer Lymphoma

U.S. FDA Resources

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 ]

Estimated Enrollment:	800
Study Start Date:	January 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	March 2013 (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

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 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932451

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Show 247 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

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00932451 History of Changes
Other Study ID Numbers:	A8081005
Study First Received:	June 30, 2009
Last Updated:	February 5, 2012
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

ClinicalTrials.gov processed this record on February 09, 2012