Metastatic MelanomaPhase 2NCT00249262
Taxoprexin Treatment for Advanced Skin Melanoma
A Phase 2 study testing Taxoprexin in people with Metastatic Melanoma, run by American Regent, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Taxoprexin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
- Patients must have at least one measurable lesion.
- Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed.
- At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
- At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and prior adjuvant chemotherapy.
- Patients must have Eastern Cooperative Oncology Group performance status of 0-2.
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- Patients must be > 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
- Patients must have adequate liver and renal function.
- Patients must have adequate bone marrow function.
- Life expectancy of at least 3 months
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
Who cannot join
- Patients who have received prior therapy with any taxane.
- Patients whose primary site was the choroid (eye).
- Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
- Patients with symptomatic brain metastasis (es).
- Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
- Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
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- Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
- Patients with unstable or serious concurrent medical conditions are excluded.
- Patients with a known hypersensitivity to Cremophor.
About this study
Official title: Phase II Open-Label Study of Weekly Taxoprexin (DHA-paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma
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.
Read the detailed description
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.
- Conditions
- Metastatic Melanoma
- Being tested
- Taxoprexin
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxoprexinDrug
Also called Docosahexaenoic acid (DHA)-paclitaxel
Administered by intravenous infusion over 1 hour infusion weekly for the first five weeks of a six week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Taxoprexin | Experimental | Taxoprexin 500 mg/m² intravenously every week for 5 weeks Receives: Drug: Taxoprexin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed every 6 weeks, up to 24 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Falone, MD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249262
- Sponsor's protocol ID
- P01-04-21
- Status last verified
- Jan 2018
- First submitted
- 3 Nov 2005
- Last updated
- 26 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-Label Study of Weekly Taxoprexin (DHA-paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma
- ClinicalTrials.gov ID
- NCT00249262
- Acronym / sponsor ID
- P01-04-21
- Conditions
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taxoprexin | Experimental | Drug: TaxoprexinTaxoprexin 500 mg/m² intravenously every week for 5 weeks |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
- Patients must have at least one measurable lesion.
- Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed.
- At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
- At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and prior adjuvant chemotherapy.
Key exclusion criteria (9 listed)
- Patients who have received prior therapy with any taxane.
- Patients whose primary site was the choroid (eye).
- Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
- Patients with symptomatic brain metastasis (es).
- Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaxoprexinAlso: Docosahexaenoic acid (DHA)-paclitaxelAdministered by intravenous infusion over 1 hour infusion weekly for the first five weeks of a six week cycle. | Drug | Taxoprexin |
Primary outcome
Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR).
Time frame: Assessed every 6 weeks, up to 24 months
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.
3 secondary outcomes
Time to Progression
Time frame: Assessed every 6 weeks until progression or death, up to 24 months
Time to Treatment Failure
Time frame: Baseline to stopping treatment
Overall Participant Survival
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Falone, MD study director
American Regent, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taxoprexin in people with Metastatic Melanoma, run by American Regent, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR). (time frame: Assessed every 6 weeks, up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.