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Study of SU11248 in Men With Advanced Prostate Cancer

NCT00299741 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-12-19

Study results available
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Summary

* There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.
* SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves.
* SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date.
* This study is directed at two populations of men with advanced prostate cancer:

1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.
2. Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy.
* Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:

1. to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and
2. to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.

Conditions

Interventions

DRUG

Sunitinib

Sunitinib 50 mg daily, 4/2 schedule

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Dror Michaelson, MD PhD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299741 on ClinicalTrials.gov