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

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

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
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

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
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
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 |