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 ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121588
First received: May 10, 2010
Last updated: November 21, 2014
Last verified: November 2014
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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 Kinase ( Alk) Gene Locus |
Resource links provided by NLM:
Drug Information available for:
Crizotinib
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Neural Crest Tumor
Neuroblastoma
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 ]
- Overall Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Plasma concentrations of crizotinib [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
- Proportion of patients with each of the ALK genetic events [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- Progression-Free Survival (PFS) [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
- Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121588
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121588
Locations
| United States, Arkansas | |
| Highlands Oncology Group | |
| Fayetteville, Arkansas, United States, 72703 | |
| Highlands Oncology Group | |
| Rogers, Arkansas, United States, 72758 | |
| United States, Missouri | |
| Site 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, 89119 | |
| Comprehensive Cancer Centers of Nevada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Oregon Health & 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 | |
| Azienda Ospedaliera San Gerardo di Monza | |
| Monza, Italy, 20052 | |
| 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 | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of, 135-710 | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
| Russian Federation | |
| Research Institute of Pulmonology | |
| Saint-Petersburg, Russian Federation, 197089 | |
| St.-Petersburg State Medical University I.P.Pavlov of Roszdrav | |
| Saint-Petersburg, Russian Federation, 197022 | |
| Taiwan | |
| National Taiwan University Hospital, Department of Internal Medicine | |
| 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, 2010-022978-14 |
| Study First Received: | May 10, 2010 |
| Last Updated: | November 21, 2014 |
| 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 Crizotinib Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2015