A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
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.
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
- Enrollment
- 529 participants
Conditions and interventions
Conditions
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.