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Completed Phase 3 Interventional Results available

A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

ClinicalTrials.gov ID: NCT00864253

Public ClinicalTrials.gov record NCT00864253. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 2, 2026, 11:18 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.

Study identification

NCT ID
NCT00864253
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Celgene
Industry
Enrollment
529 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 23, 2009 (Actual)
Primary completion
Jun 1, 2012 (Actual)
Completion
Feb 12, 2014 (Actual)
Last update posted
Oct 30, 2019

2009 – 2014

United States locations

U.S. sites
38
U.S. states
22
U.S. cities
36
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35243 —
AZ Cancer Ctr Scottsdale Arizona 85258 —
Arizona Cancer Center Tucson Arizona 85724 —
Genesis Cancer Ctr - Hot Springs Hot Springs Arkansas 71913 —
University of Arkansa for Medical Sciences Little Rock Arkansas 72205 —
Tower Cancer Research Foundation Beverly Hills California 90211 —
San Diego Pacific Oncology and Hematology Associates Encinitas California 92024 —
Loma Linda University Cancer Center Loma Linda California 92354 —
University of Southern California/Norris Cancer Center Los Angeles California 90033 —
University of CA Los Angeles Los Angeles California 90095 —
St. Mary's Medical Center San Francisco California 94117 —
University of Colorado Cancer Center Aurora Colorado 80045 —
Baptist Cancer Institute Jacksonville Florida 32207 —
Lakeland Regional Cancer Center Lakeland Florida 33805 —
University of Miami Hospital and Clincs/SCCC Miami Florida 33136 —
Waren Billhartz Cancer Center Maryville Illinois 62062 —
Indiana University Indianapolis Indiana 46202 —
IA Blood and Cancer Care, PLC Cedar Rapids Iowa 52402 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Wayne State University Detroit Michigan 48201 —
University of Minnesota Minneapolis Minnesota 55455 —
St. John's Medical Research Springfield Missouri 65807 —
Saint Louis University St Louis Missouri 63110 —
Nevada Cancer Institute Las Vegas Nevada 89135 —
Atlantic Melanoma Center Morristown New Jersey 07962 —
Piedmont Hematology Winston-Salem North Carolina 27103 —
OH State University Arthur G. James Cancer Hospital Columbus Ohio 43210 —
Integris Cancer Institute of OK Oklahoma City Oklahoma 73142 —
St. Luke's Hospital & Health Network Bethlehem Pennsylvania 18015 —
Thomas Jefferson University Philadelphia Pennsylvania 19131 —
Mary Crowley Research Center Dallas Texas 75246 —
Univ of TX MD Anderson Cancer Ctr Houston Texas 77030 —
Univ of TX Med School at Houston Houston Texas 77030 —
Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center Lubbock Texas 79410 —
Hope Oncology Richardson Texas 75080 —
Utah Cancer Specialist Salt Lake City Utah 84106 —
Univ. of Washington Medical Center/Seattle Cancer Care Alliance Seattle Washington 98109 —
Evergreen Hematology & Oncology Spokane Washington 99218 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00864253, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 30, 2019 · Synced Nov 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00864253 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →