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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511128-15-00 | Registry Identifier | CTIS (EU) |
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The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.
Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| crizotinib | Other | crizotinib oral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| crizotinib | Drug | crizotinib oral treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events leading to permanent discontinuation of study intervention | Safety data collection in this study will permit further characterization of the safety profile of crizotinib. | Baseline up to approximately 5 years |
| Number of serious adverse events reported for all participants | Safety data collection in this study will permit further characterization of the safety profile of crizotinib. | Baseline up to approximately 5 years |
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Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
Pediatric Participants (<18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.
Exclusion Criteria
Participants with any of the following characteristics/conditions will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing Municipality | 100021 | China | ||
| Beijing Cancer Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D006104 | Granuloma, Plasma Cell |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Fujian Province Oncology Hospital | Fuzhou | Fujian | 350014 | China |
| Sun Yat-Sen University Cancer center | Guangzhou | Guangdong | 510060 | China |
| The First Affiliated Hospital of Guangzhou Medical University. | Guangzhou | Guangzhou | 510120 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130028 | China |
| West China Hospital of Sichuan University | Wuhou District | Sichuan | 610041 | China |
| The First Affiliated Hospital of College of Medicine,Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Shanghai Chest Hospital | Shanghai | 200030 | China |
| ASST Monza | Monza | MB | 20900 | Italy |
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan |
| Limited Liability Company "EuroCityClinic" | Saint Petersburg | 197022 | Russia |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006099 | Granuloma |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |