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| Sponsor: | Pfizer |
|---|---|
| Information provided by (Responsible Party): | 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: A6181030, A6181064, A6181078, A6181094, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.
| Condition | Intervention |
|---|---|
|
Metastatic Breast Cancer Advanced Breast Cancer Gastrointestinal Stromal Tumor Hepatocellular Carcinoma Metastasizing Breast Cancer (F) Metastatic Castration-Resistant Prostrate Cancer Metastatic Renal Cell Cancer Non Small Cell Lung Cancer Pancreatic Islet Cell Carcinoma |
Drug: sunitinib |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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. The protocol now allows for patients on dosing regimens other than only continuous dosing (e.g. 4/2, etc.) to be enrolled if eligible. |
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 CT.gov Call Center | 1-800-718-1021 | |
| Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Show 106 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00428220 History of Changes |
| Other Study ID Numbers: | A6181114 |
| Study First Received: | January 26, 2007 |
| Last Updated: | May 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Potentially other tumor types in the future |
|
Breast Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Lung Neoplasms Gastrointestinal Stromal Tumors Carcinoma, Islet Cell Carcinoma, Hepatocellular Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
