Trials / Unknown
UnknownNCT00039156
BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Theradex · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: * Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma treated with BAY 59-8862. * Determine the overall survival in patients treated with this drug. * Determine the time to progression in patients treated with this drug. * Determine the duration of response (CR and PR) in patients treated with this drug. * Determine the qualitative and quantitative toxicity profile of this drug in this patient population. * Determine the pharmacokinetic profile of this drug in selected patients. OUTLINE: This is a multicenter, open-label study. Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years. PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ortataxel |
Timeline
- Start date
- 2002-01-01
- First posted
- 2003-01-27
- Last updated
- 2008-07-24
Locations
15 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00039156. Inclusion in this directory is not an endorsement.