Malignant MelanomaPhase 2NCT00535314
Study of Two Dose Levels of RTA 402 in Patients With Advanced Malignant Melanoma
A Phase 2 study testing RTA 402 Dose1 and RTA 402 Dose2 in people with Malignant Melanoma, run by Biogen.
Trial summary
The primary purpose of the study is to determine the proportion of patients without progression at 6-months in patients with unresectable Stage III or Stage IV melanoma who are taking RTA 402. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- RTA 402 Dose1 and RTA 402 Dose2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years of age
- Confirmed diagnosis of malignant (unresectable Stage III or Stage IV) melanoma
- Measurable disease, defined as at least 1 lesion which measures more than or equal to 20 mm by conventional techniques, or more than or equal to 10 mm by spiral CT scan, or cutaneous lesion of greater than or equal to 10 mm by caliper.
- May have received no more than 1 prior chemotherapy for metastatic disease.
- May have received prior vaccine therapy in the adjuvant setting.
- May have received cytokine therapy in the adjuvant setting and/or 1 prior cytokine therapy for metastatic disease.
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- ECOG performance of 0-1
- Must have adequate liver and renal function documented by laboratory test results.
- Must have adequate bone marrow function documented by lab results.
- Must have completed any prior chemotherapy, immunotherapy, radiation, biological, or other investigational cancer therapy at least 4 weeks prior to starting this study, and have recovered from all acute side effects. Patients receiving mitomycin C or nitrosoureas must be 6 weeks from the last administration of chemotherapy.
- Man or woman must agree to practice effective contraception during the study and for at least 2 months after the last dose of RTA 402.
- Must have life expectancy of more than 3 months.
- Must be willing and able to sign the informed consent form.
- Must be willing and able to take and document oral doses of RTA 402.
Who cannot join
- May have received no more than 1 prior chemotherapy.
- May have received no more than 1 prior cytokine therapy for metastatic disease.
- Diagnosis of ocular melanoma.
- Inability to swallow tablets or capsules
- Symptomatic malabsorptive disorder (eg, Crohn's Disease), or removal of either the terminal ileus or more than 2/3 of the small intestine.
- Active brain metastases or primary central nervous system malignancies; patients with a previously treated brain metastasis may be included provided that there is no requirement for steroids and no evidence for progression for greater than or equal to 8 weeks after treatment.
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- Active second malignancy.
- Weight loss greater than or equal to 10% over the 6 weeks prior to dosing
- Pregnant or breast feeding
- Clinically significant illnesses which could compromise participation in the study, including: uncontrolled diabetes; active or uncontrolled infection; acute or chronic liver disease; confirmed diagnosis of HIV infection; uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmia.
- Psychiatric illness that would limit compliance with study requirements.
About this study
Official title: A Multicenter, Phase II, Randomized, Open Label Trial of 2 Dose Levels of RTA 402 in Patients With Advanced Malignant Melanoma
The primary purpose of the study is to determine the proportion of patients without progression at 6-months in patients with unresectable Stage III or Stage IV melanoma who are taking RTA 402.
Read the detailed description
This is a phase II, open label, randomized study in patients with unresectable Stage III or Stage IV malignant melanoma. Patients will be randomly assigned to two different doses of RTA 402 administered orally once daily for 28 consecutive days, for up to 18 months.
- Conditions
- Malignant Melanoma
- Being tested
- RTA 402 Dose1, RTA 402 Dose2
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTA 402 Dose1Drug
RTA 402 Dose2Drug
| Study group | Role | What they receive |
|---|---|---|
| RTA 402 Dose1 | Experimental | Dose1 of RTA 402 to be administered orally once daily for 28 consecutive days, for up to 18 months. Receives: Drug: RTA 402 Dose1 |
| RTA 402 Dose2 | Experimental | Dose2 of RTA 402 to be administered orally once daily for 28 consecutive days, for up to 18 months. Receives: Drug: RTA 402 Dose2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of patients without progression at 6 months in patients with unresectable Stage III or Stage IV melanoma treated with RTA 402.
Secondary outcomes (1)
To determine the overall response rate and duration of responses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535314
- Sponsor's protocol ID
- RTA 402-C-0704
- Status last verified
- May 2025
- First submitted
- 24 Sep 2007
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II, Randomized, Open Label Trial of 2 Dose Levels of RTA 402 in Patients With Advanced Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00535314
- Acronym / sponsor ID
- RTA 402-C-0704
- Conditions
- Malignant Melanoma
- Keywords
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- First posted
- 26 Sep 2007 (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.
The primary purpose of the study is to determine the proportion of patients without progression at 6-months in patients with unresectable Stage III or Stage IV melanoma who are taking RTA 402.
Detailed description
This is a phase II, open label, randomized study in patients with unresectable Stage III or Stage IV malignant melanoma. Patients will be randomly assigned to two different doses of RTA 402 administered orally once daily for 28 consecutive days, for up to 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTA 402 Dose1 | Experimental | Drug: RTA 402 Dose1Dose1 of RTA 402 to be administered orally once daily for 28 consecutive days, for up to 18 months. |
| RTA 402 Dose2 | Experimental | Drug: RTA 402 Dose2Dose2 of RTA 402 to be administered orally once daily for 28 consecutive days, for up to 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Greater than or equal to 18 years of age
- Confirmed diagnosis of malignant (unresectable Stage III or Stage IV) melanoma
- Measurable disease, defined as at least 1 lesion which measures more than or equal to 20 mm by conventional techniques, or more than or equal to 10 mm by spiral CT scan, or cutaneous lesion of greater than or equal to 10 mm by caliper.
- May have received no more than 1 prior chemotherapy for metastatic disease.
- May have received prior vaccine therapy in the adjuvant setting.
Key exclusion criteria (11 listed)
- May have received no more than 1 prior chemotherapy.
- May have received no more than 1 prior cytokine therapy for metastatic disease.
- Diagnosis of ocular melanoma.
- Inability to swallow tablets or capsules
- Symptomatic malabsorptive disorder (eg, Crohn's Disease), or removal of either the terminal ileus or more than 2/3 of the small intestine.
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 |
|---|---|---|
| RTA 402 Dose1 | Drug | RTA 402 Dose1 |
| RTA 402 Dose2 | Drug | RTA 402 Dose2 |
Primary outcome
To determine the proportion of patients without progression at 6 months in patients with unresectable Stage III or Stage IV melanoma treated with RTA 402.
1 secondary outcome
To determine the overall response rate and duration of responses
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RTA 402 Dose1 and RTA 402 Dose2 in people with Malignant Melanoma, run by Biogen.
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 14 inclusion and 11 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: withdrawn, as of the sponsor's last update on 31 May 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the proportion of patients without progression at 6 months in patients with unresectable Stage III or Stage IV melanoma treated with RTA 402.. 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 31 May 2025.