Know Cancer

forgot password

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

Phase 2
18 Years
85 Years
Not Enrolling
Kidney Neoplasms

Thank you

Trial Information

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

Inclusion Criteria:

The following patients may be eligible for this study:

- Histologically or cytologically documented evidence of epithelial renal cell
carcinoma with at least one measurable lesion (if previous radiation treatment, the
target lesion must have demonstrated progression since the radiation)

- Patients must have had a prior nephrectomy

- Must have a life expectancy of greater than three (3) months

- Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or
relapsed less than one year after such treatment may be eligible.

Exclusion Criteria:

The following patients are not eligible for this study:

- Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?)
or relapsed more than one year after receiving such treatment are not eligible

- Patients who have had any prior chemotherapy (including a combination therapy)

- Patients with symptomatic CNS metastases or leptomeningeal involvement

- Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1

- Patients with severe cardiac insufficiency

- Patients taking Coumadin or other warfarin-containing agents with the exception of
low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports

- History of another malignancy within 3 years prior to study entry except curatively
treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ

- Patients with active or suspected acute or chronic uncontrolled infection including
abcesses or fistulae

- HIV+ patients

- Pregnant or lactating females.

Type of Study:


Study Design:

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

Outcome Measure:

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

April 2002

Completion Date:

Related Keywords:

  • Kidney Neoplasms
  • kidney cancer
  • renal cancer
  • cancer
  • tumor
  • tumour
  • neoplasm
  • carcinoma
  • clear cell
  • sarcomatoid
  • papillary
  • medullary
  • collecting duct
  • chromophobe
  • intravenous
  • epothilone
  • Neoplasms
  • Kidney Neoplasms



Cleveland Clinic Foundation Cleveland, Ohio  44195
Our Lady of Mercy Medical Center Bronx, New York  10466
University of Washington Seattle, Washington  98195
UCLA Medical Center Los Angeles, California  90095-7059
University of Maryland Baltimore, Maryland  21201
Wayne State University Karmanos Cancer Center Detroit, Michigan  48201