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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00093119
First received: October 1, 2004
Last updated: June 11, 2009
Last verified: January 2006

October 1, 2004
June 11, 2009
January 2004
Not Provided
Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
Same as current
Complete list of historical versions of study NCT00093119 on ClinicalTrials.gov Archive Site
Evaluate number of cycles required before patients achieve maximum response
Same as current
Not Provided
Not Provided
 
Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Metastases
Drug: ABI-007
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
Not Provided

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 4wks
  • History of allergy/hypersensitivity to study drug
  • Serious Medical Risk Factors determine by the investigator
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00093119
CA014-0
Not Provided
Not Provided
Celgene Corporation
Not Provided
Study Director: Michael Hawkins Celgene Corporation
Celgene Corporation
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP