A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
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|ClinicalTrials.gov Identifier: NCT00428220|
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : November 6, 2015
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Advanced Breast Cancer Metastatic Castration Resistant Prostate Cancer Metastatic Renal Cell Cancer Non-Small Cell Lung Cancer Thyroid Cancer Advanced/Metastatic Non-Small Cell Lung Cancer Advanced Gastric Cancer Gastrointestinal Stromal Tumor Hepatocellular Carcinoma Pancreatic Islet Cell Carcinoma Pancreatic Neuroendocrine Tumor||Drug: sunitinib||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||223 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2014|
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.
- Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) [ Time Frame: From first day of treatment on the current study up to 28 days post the last dose of study treatment ]Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
- Number of Participants With Treatment-emergent AEs (Treatment-Related) [ Time Frame: From first day of treatment on the current study up to 28 days post the last dose of study treatment ]Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
- Summary of Duration of Clinical Benefit [ Time Frame: From the first day of treatment in parent study until last day of treatment in A6181114 study. ]Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428220
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|