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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)

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ClinicalTrials.gov Identifier: NCT01121588
Recruitment Status : Active, not recruiting
First Posted : May 12, 2010
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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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 22, 2011
Estimated Primary Completion Date : December 29, 2018
Estimated Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Crizotinib
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01121588


Locations
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
China
Cancer institute and hospital, Chinese academy of Medical Sciences.
Beijing, China, 100021
Italy
ASST Monza
Monza, Italy, 20900
PO San Gerardo, ASST Monza
Monza, Italy, 20900
Japan
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
Taiwan
National Taiwan University Hospital, Department of Internal Medicine
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121588     History of Changes
Other Study ID Numbers: A8081013
PROFILE 1013
2010-022978-14 ( EudraCT Number )
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Pfizer:
neoplasm malignant
lymphoma
neuroblastoma
 Crizotinib
anaplastic lymphoma kinase
ALK

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