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TIC10 compound

Patients receive oral ONC201 PO on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Oral ONC201

pharmacological study

laboratory biomarker analysis

Jyoti Malhotra

This phase I trial studies the long-term side effects of the continuation of oral ONC201 in treating patients with solid tumors that have spread to other places in the body who have previously benefited from receiving this drug. Oral ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To evaluate the long-term safety and tolerability of ONC201 (oral ONC201) administered orally in patients with advanced cancers.

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:

Patients receive oral ONC201 orally (PO) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors

A Continuation Clinical Trial of Every Three-Week Dosing of Oral ONC201 in Patients With Advanced Solid Tumors

An adverse experience is defined as any unintended or abnormal clinical observation that is not of benefit to the patient. Either the condition was not present prior to exposure to the study therapy, or it has worsened in intensity or frequency following exposure to the study therapy. Descriptive statistics will be provided.

The oral ONC201 concentration, and the corresponding time, area under the curve, elimination half-life, total body clearance and volume of distribution will be determined for each patient concentration-time data using a non-compartmental model. Descriptive statistics will be provided.

Descriptive statistics on continuous data will include means, medians, standard deviations, and ranges will be provided to estimate clinical benefit rate.

National Cancer Institute (NCI)

Rutgers Cancer Institute of New Jersey

Oncoceutics, Inc.

Rutgers, The State University of New Jersey

Patients receive Oral ONC201 PO on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors	NCT02324621	Unspecified Adu...	Oral ONC201 pharmacological... laboratory biom...	18 Years -	Rutgers, The State University of New Jersey
Oral ONC201 in Treating Patients With Advanced Solid Tumors	NCT02250781	Solid Tumors	Oral ONC201	18 Years -	Rutgers, The State University of New Jersey
Oral ONC201 in Treating Patients With Advanced Solid Tumors	NCT02250781	Solid Tumors	Oral ONC201	18 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for oral onc201

Every month we try and update this database with for oral onc201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oral onc201

Every month we try and update this database with for oral onc201 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oral onc201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.