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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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. |
| ClinicalTrials.gov Identifier: NCT01121588 |
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Recruitment Status :
Active, not recruiting
First Posted : May 12, 2010
Last Update Posted : November 17, 2020
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
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 :
- 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 ]
Secondary Outcome Measures :
- 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 ]
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 |
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
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
Show 22 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| 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: | November 17, 2020 |
| Last Verified: | November 2020 |
| 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. |
Keywords provided by Pfizer:
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neoplasm malignant lymphoma neuroblastoma |
Crizotinib anaplastic lymphoma kinase ALK |
Additional relevant MeSH terms:
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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 |