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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00585195 |
Purpose
PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Anaplastic Large-Cell Lymphoma Neoplasms Anaplastic Lymphoma Kinase, Human |
Drug: PF-02341066 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of PF-02341066, A c-Met/HGFR Selective Tyrosine Kinase Inhibitor, Administered Orally To Patients With Advanced Cancer |
| Estimated Enrollment: | 175 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: PF-02341066
Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | |
| Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| Pfizer Investigational Site | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| Pfizer Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10021 | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10022 | |
| Australia, Victoria | |
| Pfizer Investigational Site | Recruiting |
| East Melbourne, Victoria, Australia, 3002 | |
| Korea, Republic of | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A8081001 |
| Study First Received: | December 29, 2007 |
| Last Updated: | January 14, 2010 |
| ClinicalTrials.gov Identifier: | NCT00585195 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Tumors positive for c-Met mutations or amplifications; or for ALK fusion gene or ALK amplifications Tumors with chromosomal translocations at the ROS gene |
|
Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |