A Phase 2 interventional study of Taxoprexin in Metastatic Melanoma, sponsored by American Regent, Inc.. Completed. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by American Regent, Inc. · Phase 2, Interventional, and Treatment
To evaluate objective response rate and duration of response to weekly Taxoprexin®.
To evaluate the safety profile of weekly Taxoprexin® in this patient population.
To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic malignant melanoma being treated with weekly Taxoprexin® Injection.
This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents including Interleukin-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 30 is below the median of 38 across 2,351 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 500 mg/m² intravenously every week for 5 weeks
Drug: Taxoprexin
Administered by intravenous infusion over 1 hour infusion weekly for the first five weeks of a six week cycle.
Also known as: Docosahexaenoic acid (DHA)-paclitaxel
Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR).
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 24 months
Time to Progression
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 24 months
Time to Treatment Failure
Time to Failure 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
Overall Participant Survival
Overall survival was defined as the time from the day of randomization to participant death or last date that participant was known to be alive, whichever occurs first. Survival data was collected every two months while participants were off-study.
Time frame: Up to 24 months
No study locations are listed for this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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American Regent, Inc.