A Phase 3 interventional study of Taxoprexin and Dacarbazine in Malignant Melanoma, sponsored by American Regent, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by American Regent, Inc. · Phase 3, Interventional, and Treatment
The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.
This was a randomized, multi-center, open-label Phase III study in patients with histologically confirmed metastatic malignant melanoma. Patients received either Taxoprexin® at a starting dose of 900 mg/m2 intravenously by 2-hour infusion on Day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m2 intravenously over at least 30 minutes once every 3 weeks. Treatment continued until progression of disease, intolerable toxicity, refusal of continued treatment by the patient, or, in the investigator's opinion, treatment discontinued. Disease status was assessed every 6 to 8 weeks using standard imaging techniques. All images were forwarded to the sponsor and archived. Following the end of protocol treatment, further treatment was at the investigator's discretion but no cross-over was planned. All patients were followed until death
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 393 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →American Regent, Inc. is the lead sponsor of 53 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Taxoprexin® 900 mg/m² intravenously every 3 weeks
Drug: Taxoprexin
Dacarbazine 1000 mg/m² intravenously every 3 weeks.
Drug: Dacarbazine
Administered by intravenous infusion over 2 hour infusion on Day 1 followed by a 20-day observation period for a total of 21 days (three weeks) per course
Also known as: Docosahexaenoic acid (DHA)-paclitaxel
Administered by intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (three weeks) per course
Also known as: Imidazole carboxamide
Overall Participant Survival
Overall survival was defined as the time from the day of randomization to participant death or the termination of the study, whichever occurs first. Participants were contacted monthly for survival information.
Time frame: Up to 36 months
Percentage of Participants Who Achieved an Objective Complete Response or Partial Response
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.
Time frame: Assessed every 6 weeks, up to 38 months
Duration of Response
Duration of overall response was a measurement from the time measure criteria was met for confirmed complete response or partial response (whichever was first recorded) until the first date that recurrent of progressive disease was objectively documented (taking as reference for progressive disease the smallest measurement recorded since treatment started).
Time frame: Assessed every 6 weeks, up to 36 months
Time to Progression (TPP)
Progression free survival time was defined as the time from the day of randomization to the start of documented progression, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the sum of longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions
Time frame: Assessed every 6 weeks until progression or death, up to 36 months
Time to Failure (TTF)
Time to Failure (TTF) was defined as the time from the day of randomization to the discontinuation of protocol treatment for any reason.
Time frame: Baseline to stopping treatment, up to 36 months
This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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American Regent, Inc.