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

Primary Purpose

Melanoma, Metastases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABI-007
Sponsored by
Celgene
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abraxis BioScience Inc.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate number of cycles required before patients achieve maximum response

Full Information

First Posted
October 1, 2004
Last Updated
April 25, 2017
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00093119
Brief Title
Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
Official Title
A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Metastases
Keywords
Metastatic Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ABI-007
Primary Outcome Measure Information:
Title
Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
Secondary Outcome Measure Information:
Title
Evaluate number of cycles required before patients achieve maximum response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hawkins
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Abraxis BioScience Inc.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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