NCT03733119

ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well Akt/ERK inhibitor ONC201 (ONC201) with a methionine-restricted (MR) diet works in treating participants with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the death of a cell. ONC201 is able to target tumor cells to get rid of them, but does not affect normal cells. MR diet is a methionine-free amino acid modified medical food. The addition of an intermittent MR diet may enhance the activity of ONC201. Giving ONC201 and an MR diet may work better in treating participants with breast cancer.

Detailed description

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Akt/ERK Inhibitor ONC201	Given PO
DIETARY_SUPPLEMENT	Methionine-Restricted Diet	Given PO

Timeline

• Start date: 2018-11-13
• Primary completion: 2021-02-13
• Completion: 2021-02-13
• First posted: 2018-11-07
• Last updated: 2022-03-10
• Results posted: 2022-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study