Oral ONC201 in Treating Patients With Advanced Solid Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||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|
- Dose limiting toxicity rate during cycle 1 of treatment with oral ONC201 [ Time Frame: Day 21 ]
- Recommended phase II dose (RP2D) for oral ONC201 [ Time Frame: At the end of 6 weeks therapy ]
- Frequency of toxicities associated with ONC201 [ Time Frame: Up to 4 weeks after end of study treatment ]
- Pharmacokinetics of oral ONC201 - Half-life [ Time Frame: Up to 4 weeks of therapy ]
- Pharmacokinetics of oral ONC201 - Maximum concentration [ Time Frame: Up to 4 weeks of therapy ]
- Pharmacokinetics of oral ONC201 - Area under the curve (AUC) over time [ Time Frame: Up to 4 weeks of therapy ]
- Response rate of oral ONC201 in patients with advanced solid tumors [ Time Frame: 3 months ]
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Oral ONC201)
Patients receive Oral ONC201 PO on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Oral ONC201
I. To determine the recommended phase II dose of single agent ONC201 orally once every three weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02250781
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Mark N. Stein 732-235-6031 firstname.lastname@example.org|
|Principal Investigator: Mark N. Stein|
|Principal Investigator:||Mark Stein||Rutgers Cancer Institute of New Jersey|