Trials / Withdrawn
WithdrawnNCT00040989
BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
Detailed description
OBJECTIVES: * Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722. * Determine the duration of response, time to progression, and survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAY 56-3722 | |
| PROCEDURE | enzyme inhibitor therapy |
Timeline
- First posted
- 2003-01-27
- Last updated
- 2013-07-10
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00040989. Inclusion in this directory is not an endorsement.