Evaluation of Bay 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044551
• Other study ID #: 100389
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2002
• Last updated: October 10, 2013
• Start date: February 2002
• Est. completion date: July 2003

Study information

• Verified date: October 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin's Lymphoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: - Measurable disease as defined by the presence of at least one measurable lesion - Failed at least one prior therapy or has achieved remission but has progressed or relapsed within 6 months of therapy - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and kidney function Exclusion Criteria: - Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - Others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Taxane (Cytotoxic, BAY59-8862)
Daily 1 h infusion every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Netherlands,  United Kingdom, 

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