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

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Pfizer

Status

Completed

Conditions

Metastatic Renal Cell Cancer
Metastatic Castration Resistant Prostate Cancer
Gastrointestinal Stromal Tumor
Non-Small Cell Lung Cancer
Pancreatic Islet Cell Carcinoma
Advanced/Metastatic Non-Small Cell Lung Cancer
Hepatocellular Carcinoma
Thyroid Cancer
Metastatic Breast Cancer
Pancreatic Neuroendocrine Tumor
Advanced Breast Cancer
Advanced Gastric Cancer

Treatments

Drug: sunitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00428220
2006-006538-16 (EudraCT Number)
A6181114

Details and patient eligibility

About

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.

Enrollment

223 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

223 participants in 1 patient group

A
Experimental group
Description:
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.
Treatment:
Drug: sunitinib

Trial contacts and locations

113

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Data sourced from clinicaltrials.gov

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