RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER (NCT02029729) | Clinical Trial Compass
CompletedPhase 1
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER
United States11 participantsStarted 2013-12-31
Plain-language summary
This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients with advanced solid tumors that are refractory after standard of care therapy for the disease. The results of this study will help provide clinical information for the design and conduct of further clinical studies with RTA 408 in cancer patients.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult male and female patients (18 to 75 years of age, inclusive);
. Histologically or cytologically documented advanced NSCLC who have Stage IIIB/Stage IV disease, or recurrent disease following radiation therapy or surgical resection or advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
. Patients must have experienced disease recurrence or progression during or after prior treatment with one or more prior standard systemic therapies;
. Patients with epidermal growth factor receptor (EGFR) overactivity mutations or anaplastic lymphoma kinase (ALK) rearrangements must have received tyrosine-kinase inhibitor (TKI) therapy prior to consideration for enrollment;
. Life expectancy \> 3 months;
. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Determination
Timeframe: 1 year (28-day cycles, up to 12 cycles per patient)
. Have discontinued previous treatments for cancer and recovered from all acute toxic effects of prior systemic therapy (except alopecia) to grade ≤1;
. Have adequate bone marrow reserve and organ function at screening as follows:
Exclusion criteria
. Concurrent active malignancy other than adequately treated nonmelanomatous cell skin cancers, superficial bladder cancer, or carcinoma in situ of the cervix or breast;
. Patients who previously had brain metastases (screening not required) unless they have met all of the following criteria:
. Patient had a resection and/or completed a course of cranial irradiation; and
. Patient has no worsening central nervous system symptoms; and
. Patient has discontinued all corticosteroids for that indication for at least 2 weeks;
. Cardiovascular abnormalities:
. Evidence of poor cardiovascular function defined as b-type natriuretic peptide (BNP) \> 100 pg/mL, or history of congestive heart failure, unstable angina, uncontrolled hypertension, or clinically significant ventricular arrhythmias at screening;
. Myocardial infarction within 6 months prior to screening;