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An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)


Inclusion Criteria:



- Measurable disease as defined by the presence of at least one measurable lesion

- Patients must have received at least 3 weeks of continuous therapy with Taxane -
patient must subsequently develop progressive disease either during treatment or
within 6 months after treatment

- 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; brain
metastasis, 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:

10653

NCT ID:

NCT00044538

Start Date:

December 2001

Completion Date:

June 2004

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Taxane
  • Lung cancer, non-small cell
  • NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

New Britain, Connecticut  06052
Phoenix, Arizona  85012
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Louisville, Kentucky  40207
Metairie, Louisiana  70006