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 range18 Years – 75 Years
SexALL
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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;
✓. 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:
What they're measuring
1
Dose Determination
Timeframe: 1 year (28-day cycles, up to 12 cycles per patient)
. 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;