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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121588
Recruitment Status : Active, not recruiting
First Posted : May 12, 2010
Last Update Posted : November 20, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Neoplasms Malignant Drug: Crizotinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b Open-label Study Of The Safety And Clinical Activity Of Crizotinib (Pf-02341066) In Tumors With Genetic Events Involving The Anaplastic Lymphoma Kinase (Alk ) Gene Locus
Actual Study Start Date : March 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Crizotinib

Arm Intervention/treatment
Experimental: Crizotinib Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Other Name: PF-02341066

Primary Outcome Measures :
  1. 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 ]
  2. Overall Response Rate [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 36 months ]
  2. Plasma concentrations of crizotinib [ Time Frame: 30 Months ]
  3. Overall Survival [ Time Frame: 36 Months ]
  4. Proportion of patients with each of the ALK genetic events [ Time Frame: 36 Months ]
  5. Progression-Free Survival (PFS) [ Time Frame: 36 Months ]
  6. Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121588

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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
United States, Missouri
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Oregon Health & Science University
Portland, Oregon, United States, 97239
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Greenville Hospital System, Institute for Translational Oncology Research
Greenville, South Carolina, United States, 29605
China, Guangdong
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Cancer institute and hospital, Chinese academy of Medical Sciences.
Beijing, China, 100021
ASST Monza
Monza, Italy, 20900
PO San Gerardo, ASST Monza
Monza, Italy, 20900
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Russian Federation
St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
Saint-Petersburg, Russian Federation, 197022
Research Institute of Pulmonology
Saint-Petersburg, Russian Federation, 197089
National Taiwan University Hospital, Department of Internal Medicine
Taipei, Taiwan, 100
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT01121588     History of Changes
Other Study ID Numbers: A8081013
2010-022978-14 ( EudraCT Number )
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

Keywords provided by Pfizer:
neoplasm malignant
anaplastic lymphoma kinase

Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action