An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

This study is currently recruiting participants.

Verified May 2013 by Pfizer

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01121588

First received: May 10, 2010

Last updated: May 3, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 10, 2010

Last Updated Date

May 3, 2013

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Objective Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Objective Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01121588 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression-Free Survival (PFS) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Duration or Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Plasma concentrations of crizotinib [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Proportion of patients with each of the ALK genetic events [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when evaluable [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Duration or Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Plasma concentrations of crizotinib [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Proportion of patients with each of the ALK genetic events [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when evaluable [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Official Title ^ICMJE

Phase 1B Open-Label Study Of The Safety And Clinical Activity Of Crizotinib (PF-02341066) In Tumors With Genetic Events Involving The Anaplastic Lymphoma (ALK) Gene Locus

Brief Summary

This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neoplasms Malignant

Intervention ^ICMJE

Drug: Crizotinib

Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule

Other Name: PF-02341066

Study Arm (s)

Experimental: Crizotinib

Intervention: Drug: Crizotinib

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

histologically or cytologically proven diagnosis of malignancy other than NSCLC
positive for translocation or inversion event involving the ALK gene locus
positive for ALK amplification events
positive for ALK activating point mutations

Exclusion Criteria:

mutations of amplifications involving the c-Met gene but not the ALK gene
concurrent treatment on another therapeutic clinical trial
prior therapy specifically directed against ALK

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States, Canada, China, Italy, Japan, Korea, Republic of, Russian Federation, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01121588

Other Study ID Numbers ^ICMJE

A8081013, PROFILE 1013

Has Data Monitoring Committee

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

May 2013

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

To Top