NCT02250781

Oral ONC201 in Treating Patients With Advanced Solid Tumors

A First-in-Human Phase I Single-Agent Open-Label Dose-Escalation Study of Every Three-Week Dosing of Oral ONC201 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of Oral ONC201 in treating patients with advanced solid tumors. Oral ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of single agent ONC201 orally once every three weeks. SECONDARY OBJECTIVES: I. To characterize pharmacokinetics of ONC201. II. To assess serum biomarkers of therapeutic response to ONC201. III. To assess preliminary antitumor activity of ONC201 as a single agent in advanced solid tumors. OUTLINE: This is a dose-escalation study. Patients receive ONC201 orally (PO) on day 1. Courses repeat every 21 days for a total of 2 courses. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Oral ONC201	Given PO

Timeline

• Start date: 2015-01-12
• Primary completion: 2018-10-18
• Completion: 2018-10-25
• First posted: 2014-09-26
• Last updated: 2019-05-22

Locations

1 site across 1 country: United States