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A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma, Metastases

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Trial Information

A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

Inclusion Criteria:

- Confirmed Metastatic Melanoma

- At least 18 years old

- No other active malignancy

- Hemoglobin at least 9

- Platelet Count at least 100,000 cells/mm3

- ANC at least 1500 cells/mm3

- AST & ALT less than 2.5X upper limit of normal

- Total bilirubin less than 1.5mg/dL

- Creatine less than 1.5 mg/dL

- Alkaline phosphatase less than 2.5X upper limit of normal

- Life expectancy of at least 12 weeks

- ECOG performance status of 0-1

- Patient must provide informed consent

- Patient must provide authorization to disclose

Exclusion Criteria:

- Evidence of active brain metastases

- The only evidence of metastasis is lytic or blastic bone metastases

- Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater
than 2

- Received radiotherapy in last 4wks, except if to a non-target lesion only

- Clinically significant concurrent illness

- Investigator's opinion that patient unlikely to complete study

- Cytotoxic chemotherapeutic agent treatment or investigational drug within previous

- History of allergy/hypersensitivity to study drug

- Serious Medical Risk Factors determine by the investigator

Type of Study:


Study Design:

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

Outcome Measure:

Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.

Principal Investigator

Michael Hawkins

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Melanoma
  • Metastases
  • Metastatic Melanoma
  • Melanoma
  • Neoplasm Metastasis



Abraxis BioScience Inc. Durham, North Carolina  27703