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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

100389

NCT ID:

NCT00044551

Start Date:

February 2002

Completion Date:

July 2003

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Taxane
  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Hinsdale, Illinois  60521
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Seattle, Washington  98195
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Milwaukee, Wisconsin