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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 Sep 13, 2026, 11:12 PM EDT

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 22, 2009
Primary completion
May 31, 2012
Completion
Feb 11, 2014
Last update posted
Oct 29, 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 29, 2019 · Synced Sep 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00864253 live on ClinicalTrials.gov.

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