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NCT00864253 · ClinicalTrials.gov registry record · Phase 3
A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
A Phase 3 study of Malignant Melanoma, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
- 20
- Study locations
NCT00864253: Completed Phase 3 study of Malignant Melanoma, sponsored by Celgene.
NCT00864253 is a Phase 3 study of Malignant Melanoma that has completed, run by Celgene. The registered enrollment target is 529 participants, above the 164-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (223% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00864253, a Phase 3 study of Malignant Melanoma, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who b
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 |
What the finished NCT00864253 record still lists
NCT00864253 is an interventional study that assigns participants to a tested intervention. The registered 529 participants enrollment target is mid-sized for trials with a published cap, above the 164-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (223% higher).
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.
NCT00864253 names 20 study sites across 11 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT00864253?
The interventions under investigation include: Dacarbazine (DRUG), ABI-007 (DRUG).
Who is sponsoring clinical trial NCT00864253?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00864253's enrollment target sits among peer trials
529 3rd of 28 higher than 26 of 28 other Malignant Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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