Trials / Completed
CompletedNCT00599313
Phase II Sunitinib Prog Met AIPC
Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-based Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- US Oncology Research · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.
Detailed description
The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sunitinib | 50 mg/day orally each of Days 1-28 of each 6 week cycle |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2008-01-23
- Last updated
- 2018-10-25
- Results posted
- 2016-12-08
Locations
45 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00599313. Inclusion in this directory is not an endorsement.