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| Study 19 of 884 for search of: | United States, Delaware |
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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00267748 |
Purpose
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.
The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future. The second part of the trial is open to enrollment
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell |
Drug: Sunitinib Malate Continuous Daily Dosing Drug: Sunitinib Malate Schedule 4/2 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial) |
| Estimated Enrollment: | 282 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| C: Experimental |
Drug: Sunitinib Malate Continuous Daily Dosing
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
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| A: Experimental |
Drug: Sunitinib Malate Schedule 4/2
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
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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 Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 159 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6181065 |
| Study First Received: | December 20, 2005 |
| Last Updated: | January 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00267748 |
| Health Authority: | United States: Food and Drug Administration |
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Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Sunitinib Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |
