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)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121588
First received: May 10, 2010
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neoplasms Malignant |
Drug: Crizotinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 (ALK) Gene Locus |
Resource links provided by NLM:
Genetics Home Reference related topics:
neuroblastoma
Drug Information available for:
Crizotinib
U.S. FDA Resources
Further study details as provided by Pfizer:
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 ] [ Designated as safety issue: Yes ]
- Objective Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Duration or Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Plasma concentrations of crizotinib [ Time Frame: 30 months ] [ Designated as safety issue: No ]
- Proportion of patients with each of the ALK genetic events [ Time Frame: 30 months ] [ Designated as safety issue: No ]
- Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when evaluable [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Crizotinib |
Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Other Name: PF-02341066
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121588
Hide Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | |
| Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Hide Study LocationsLocations
| United States, Arkansas | |
| Pfizer Investigational Site | Recruiting |
| Fayetteville, Arkansas, United States, 72703 | |
| Pfizer Investigational Site | Recruiting |
| Rogers, Arkansas, United States, 72758 | |
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Boynton Beach, Florida, United States, 33437 | |
| Pfizer Investigational Site | Recruiting |
| Boynton Beach, Florida, United States, 33435 | |
| Pfizer Investigational Site | Recruiting |
| Miami, Florida, United States, 33136 | |
| United States, Missouri | |
| Pfizer Investigational Site | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Pfizer Investigational Site | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | Recruiting |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| Pfizer Investigational Site | Recruiting |
| Portland, Oregon, United States, 97239 | |
| United States, South Carolina | |
| Pfizer Investigational Site | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Canada, Alberta | |
| Pfizer Investigational Site | Not yet recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Pfizer Investigational Site | Not yet recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| China, Guangdong | |
| Pfizer Investigational Site | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| China | |
| Pfizer Investigational Site | Recruiting |
| Beijing, China, 100021 | |
| Italy | |
| Pfizer Investigational Site | Not yet recruiting |
| Bologna, Italy, 40138 | |
| Pfizer Investigational Site | Not yet recruiting |
| Bolzano, Italy, 39100 | |
| Pfizer Investigational Site | Not yet recruiting |
| Catania, Italy, 95124 | |
| Pfizer Investigational Site | Not yet recruiting |
| Firenze, Italy, 50134 | |
| Pfizer Investigational Site | Recruiting |
| Monza, Italy, 20052 | |
| Pfizer Investigational Site | Not yet recruiting |
| Torino, Italy, 10126 | |
| Japan | |
| Pfizer Investigational Site | Recruiting |
| Nagoya, Aichi, Japan | |
| Pfizer Investigational Site | Recruiting |
| Chuo-ku, Tokyo, Japan | |
| Pfizer Investigational Site | Recruiting |
| Fukuoka, Japan | |
| Korea, Republic of | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Russian Federation | |
| Pfizer Investigational Site | Recruiting |
| Saint-Petersburg, Russian Federation, 197089 | |
| Pfizer Investigational Site | Recruiting |
| Saint-Petersburg, Russian Federation, 197022 | |
| Taiwan | |
| Pfizer Investigational Site | Not yet recruiting |
| Taichung, Taiwan, 40705 | |
| Pfizer Investigational Site | Not yet recruiting |
| Taipei, Taiwan, 100 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01121588 History of Changes |
| Other Study ID Numbers: | A8081013, PROFILE 1013 |
| Study First Received: | May 10, 2010 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
neoplasm malignant lymphoma neuroblastoma |
Crizotinib anaplastic lymphoma kinase ALK |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Non-Small-Cell Lung Lymphoma Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013