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

NCT ID: NCT01121588

Last Updated: 2025-01-23

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-22

Study Completion Date

2023-09-07

Brief Summary

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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

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Conditions

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Neoplasms Malignant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crizotinib

Group Type EXPERIMENTAL

Crizotinib

Intervention Type DRUG

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

Interventions

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Crizotinib

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

Intervention Type DRUG

Other Intervention Names

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PF-02341066

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status

Highland Oncology Group

Springdale, Arkansas, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

OHSU Center for Health and Healing 2

Portland, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Greenville Health System, Institute for Translational Oncology Research

Greenville, South Carolina, United States

Site Status

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Chaoyang District, China

Site Status

SUN Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Centro di Ricerca di Fase 1 ASST-Monza

Monza, , Italy

Site Status

PO San Gerardo, ASST Monza-U.O Ematologia

Monza, , Italy

Site Status

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status

GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health

Saint Petersburg, , Russia

Site Status

Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva

Saint Petersburg, , Russia

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

National Taiwan University Hospital, Department of Internal Medicine

Taipei, , Taiwan

Site Status

Countries

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United States China Italy Japan Russia South Korea Taiwan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Other Identifiers

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2010-022978-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A8081013

Identifier Type: -

Identifier Source: org_study_id

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