Study of Two Dose Levels of RTA 402 in Patients With Advanced Malignant Melanoma

May 26, 2025 updated by: Biogen

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RTA 402 Dose1
Dose1 of RTA 402 to be administered orally once daily for 28 consecutive days, for up to 18 months.
Drug: RTA 402 Dose1
Experimental: RTA 402 Dose2
Dose2 of RTA 402 to be administered orally once daily for 28 consecutive days, for up to 18 months.
Drug: RTA 402 Dose2

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
To determine the overall response rate and duration of responses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimated)

September 26, 2007

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTA 402-C-0704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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