Finding studies
Finding studies
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Lead
University of Wisconsin, Madison
With
PRIMARY OBJECTIVES: I. To determine objective response rate (ORR) to ONC201 with a methionine-restricted diet in patients with metastatic triple negative breast cancer (TNBC). SECONDARY OBJECTIVES: I. To determine progression-free survival (PFS) to ONC201 with a methionine-restricted diet in patients with metastatic TNBC. II. To determine clinical benefit rate (complete or partial response plus stable disease) (CBR) at 4 months to ONC201 with a methionine-restricted diet in patients with metastatic TNBC. III. To determine overall survival (OS) to ONC201 with a methionine-restricted diet in patients with metastatic TNBC. IV. To assess metabolic indices in patients with metastatic TNBC treated with ONC201 and a methionine-restricted diet. V. To assess the expression of TRAIL receptor in circulating tumor cells (CTCs) prior, during and upon progression in patients with metastatic TNBC treated with ONC201 with a methionine-restricted diet. EXPLORATORY OBJECTIVES: I. To determine time to development of brain metastases or worsening of brain metastases in patients with metastatic TNBC treated with ONC201 with a methionine-restricted diet. STUDY DESIGN Patients with metastatic TNBC will be enrolled in a single-arm study evaluating ONC201 with a methionine-restricted diet. After completion of study treatment, participants are followed up every 3 months for 2 years.
Age
18–74
Sex
FEMALE
Healthy volunteers
Not accepted