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 : October 7, 2021
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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 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

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 |
- 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, 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

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

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01121588 |
Other Study ID Numbers: |
A8081013 PROFILE 1013 2010-022978-14 ( EudraCT Number ) |
First Posted: | May 12, 2010 Key Record Dates |
Last Update Posted: | October 7, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
neoplasm malignant lymphoma neuroblastoma |
Crizotinib anaplastic lymphoma kinase ALK |
Lymphoma Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Crizotinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |