Status and phase
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About
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.
Full description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Enrollment
Sex
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Volunteers
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:
Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) from screening through 3 months after taking the final dose of RTA 408;
Female patients of childbearing potential must be non-pregnant, non-lactating, and have a negative pregnancy test result prior to enrollment in the study;
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:
Cardiovascular abnormalities:
Known hepatic impairment including cirrhosis, known renal impairment including renal insufficiency or glomerulonephritis and severe cerebral or peripheral vascular disease;
Any gastrointestinal disorder with diarrhea as a major symptom, such as Crohn's, or pre- existing chronic diarrhea CTCAE Grade ≥ 2 of any etiology. Included are malabsorption disorders or surgical procedures that in the opinion of the investigator may affect absorption of study drug;
Known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required).;
Major surgery within 21 days before Study Day 1;
Have taken any of the following drugs within 7 days prior to Study Day 1:
Known or suspected active drug or alcohol abuse;
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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