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

April 25, 2017 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27703
        • Abraxis BioScience Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Evaluate number of cycles required before patients achieve maximum response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Michael Hawkins, Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

October 1, 2004

First Submitted That Met QC Criteria

October 1, 2004

First Posted (ESTIMATE)

October 4, 2004

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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