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

Phase 2
18 Years
85 Years
Not Enrolling

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Trial Information

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

Inclusion Criteria

Inclusion Criteria

The following patients may be eligible for this study:

- Patients with advanced metastatic melanoma defined as poor prognosis Stage III
melanoma and Stage IV disease, which has been histologically or cytologically
confirmed with at least one measurable lesion not including bone metastases (if
previous radiation treatment, the target lesion must have demonstrated progression
since the radiation)

- Patients with poor prognosis Stage III melanoma must have locally advanced
unresectable disease that is measurable (repeat histological or cytological
confirmation is not necessary at the time of study entry if previous results are
available and there is no question in the investigator's opinion as to the diagnosis)

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

- Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but
must have been completed > 4 weeks prior to treatment

- Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to

- Patient has no major impairment of hematological function (red blood cell
transfusions and repeat evaluations for study entry are allowed).

Exclusion Criteria

The following patients are not eligible for this study:

- Patients with choroidal ocular melanoma

- Patients with symptomatic CNS metastases or leptomeningeal involvement

- Patients with renal or hepatic dysfunction

- 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

- Patients who have received any investigational compound or anti-melanoma vaccine
within the past 28 days or those who are planning to receive other investigational
drugs while participating in the study

- Patients who had received radiotherapy within the last 4 weeks to a site which will
be the reference for disease assessment (however, new or progressive lesions in the
previously irradiated fields of these patients may be used for disease assessment and
patients must have recovered from the side effects of radiotherapy)

- Patients receiving chemotherapy within the last four weeks

- History of another malignancy within 5 years prior to study entry except curatively
treated non-melanoma skin 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:

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

Outcome Measure:

Tumor response (complete response (CR), partial response (PR), stable disease (SD))

Outcome Description:

Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.

Outcome Time Frame:

at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

  • Melanoma
  • melanoma
  • cancer
  • tumor
  • tumour
  • malignant
  • metastatic
  • intravenous
  • epothilone
  • Melanoma



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
University of Colorado Denver, Colorado  80217
Duke University Medical Center Durham, North Carolina  27710
Comprehensive Cancer Center@ Our Lady if Mercy Medical Center Bronx, New York  10466-2697
Oklahoma Oncology, Inc. Tulsa, Oklahoma  74104
UPMC Health Systems Pittsburgh, Pennsylvania  15213