Trial record 2 of 2 for: A8081007

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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

Tracking Information

First Received Date ^ICMJE

June 30, 2009

Last Updated Date

February 11, 2013

Start Date ^ICMJE

September 2009

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00932893 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

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

Study Arm (s)

Experimental: PF-02341066
Intervention: Drug: PF-02341066
Active Comparator: Pemetrexed or Docetaxel
Investigator selection of either pemetrexed or docetaxel as the active comparator
Interventions:
- Drug: Pemetrexed
- Drug: Docetaxel

Publications *

Tamiya A, Okamoto I, Miyazaki M, Shimizu S, Kitaichi M, Nakagawa K. Severe acute interstitial lung disease after crizotinib therapy in a patient with EML4-ALK-positive non-small-cell lung cancer. J Clin Oncol. 2013 Jan 1;31(1):e15-7. doi: 10.1200/JCO.2012.43.3730. Epub 2012 Nov 19.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

347

Estimated Completion Date

February 2013

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00932893

Other Study ID Numbers ^ICMJE

A8081007

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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