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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00428220
First received: January 26, 2007
Last updated: July 9, 2014
Last verified: July 2014
  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: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The objective of the study is to assess long term safety and tolerability of patients enrolling from prior Sutent clinical studies. Duration of clinical benefit will be assessed for patients enrolling from protocol A6181111; PNET. [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: July 2007
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428220

  Show 106 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00428220     History of Changes
Other Study ID Numbers: A6181114
Study First Received: January 26, 2007
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 29, 2014