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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00428220 |
Purpose
This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181107, A6181108, A6181110, A6181111, or A6181112.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell Breast Neoplasms Carcinoma, Islet Cell Gastrointestinal Stromal Tumors |
Drug: sunitinib |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label Sunitinib Malate (SU011248) Continuation Protocol For Patients Who Have Completed A Prior Sunitinib Study And Are Judged By The Investigator To Have The Potential To Benefit From Sunitinib Treatment. |
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Sunitinib will be administered in a continuous daily dose (oral, once per day). Starting dose will be 37.5 mg daily unless the patient was on a different dose (25 mg or 50 mg daily) on the previous trial. In that case, they will begin treatment on this study at the same dose used at the end of the previous study.
|
Drug: sunitinib
sunitinib
|
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 129 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6181114 |
| Study First Received: | January 26, 2007 |
| Last Updated: | April 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00428220 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Urinary Tract Neoplasm Gastrointestinal Diseases Pancreatic Neoplasms Urogenital Neoplasms Urologic Neoplasms Renal Cancer Urologic Diseases Sunitinib Kidney Neoplasms Kidney Diseases Breast Diseases Endocrine Gland Neoplasms Kidney Cancer Digestive System Neoplasms |
Skin Diseases Carcinoma, Islet Cell Breast Neoplasms Endocrine System Diseases Angiogenesis Inhibitors Carcinoma Digestive System Diseases Carcinoma, Renal Cell Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gastrointestinal Stromal Tumors Neoplasms, Glandular and Epithelial |
|
Antineoplastic Agents Gastrointestinal Diseases Pancreatic Neoplasms Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Sunitinib Kidney Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Breast Diseases |
Endocrine Gland Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Skin Diseases Growth Substances Carcinoma, Islet Cell Breast Neoplasms Endocrine System Diseases Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Carcinoma, Renal Cell Gastrointestinal Neoplasms |
