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A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
NCT00864253 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Dacarbazine
- DRUG ABI-007
Study Locations (20)
California
- Tower Cancer Research Foundation — Beverly Hills
- San Diego Pacific Oncology and Hematology Associates — Encinitas
- Loma Linda University Cancer Center — Loma Linda
- University of Southern California/Norris Cancer Center — Los Angeles
- University of CA Los Angeles — Los Angeles
- St. Mary's Medical Center — San Francisco
Florida
- Baptist Cancer Institute — Jacksonville
- Lakeland Regional Cancer Center — Lakeland
- University of Miami Hospital and Clincs/SCCC — Miami
Arizona
- AZ Cancer Ctr — Scottsdale
- Arizona Cancer Center — Tucson
Arkansas
- Genesis Cancer Ctr - Hot Springs — Hot Springs
- University of Arkansa for Medical Sciences — Little Rock
Alabama
- University of Alabama at Birmingham — Birmingham
Colorado
- University of Colorado Cancer Center — Aurora
Illinois
- Waren Billhartz Cancer Center — Maryville
Indiana
- Indiana University — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2009-04-23 |
| Est. Completion | 2014-02-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00864253
The ClinicalTrials.gov registry entry for NCT00864253 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 529 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Dacarbazine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00864253 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00864253 about?
NCT00864253 is a clinical study titled "A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma". 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 paclitaxe...
What is the current status of trial NCT00864253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2009-04-23. Estimated completion is 2014-02-12.
What conditions does trial NCT00864253 study?
This clinical trial studies the following conditions: Malignant Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00864253?
The interventions under investigation include: Dacarbazine (DRUG), ABI-007 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00864253?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00864253 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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