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A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428220
First Posted: January 29, 2007
Last Update Posted: November 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.

Condition Intervention
Metastatic Breast Cancer [F] 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 226
Study Start Date: July 2007
Study Completion Date: September 2014
Primary Completion Date: August 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have ended treatment from one of the following sunitinib studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.

Exclusion Criteria:

  • See inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

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


  Show 114 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00428220     History of Changes
Other Study ID Numbers: A6181114
2006-006538-16 ( EudraCT Number )
First Submitted: January 26, 2007
First Posted: January 29, 2007
Results First Submitted: July 26, 2015
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015
Last Verified: October 2015

Keywords provided by Pfizer:
Potentially other tumor types in the future

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Hepatocellular
Stomach Neoplasms
Thyroid Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Carcinoid Tumor
Prostatic Neoplasms
Gastrointestinal Stromal Tumors
Adenoma, Islet Cell
Carcinoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases