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CompletedNCT00093119Updated Apr 26, 2017

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

A Phase 2 interventional study of ABI-007 in Melanoma and Metastases, sponsored by Celgene. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-26.

Sponsored by Celgene · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Melanoma
  • Metastases

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Keywords

  • Metastatic Melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 75 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Interventions

  • DrugABI-007
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Evaluate number of cycles required before patients achieve maximum response

07

Study locations

1 site
  • Abraxis BioScience Inc.
    Durham, North Carolina 27703, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00093119
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Oct 4, 2004
Start date
Jul 2003
Primary completion
Feb 2005
Last update
Apr 26, 2017

Study contacts

Michael Hawkins
study director · Celgene Corporation
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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