Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors

Unspecified Adult Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324621
• Other study ID #: 051407
• Secondary ID: NCI-2014-0204305
• Status: Completed
• Phase: Phase 1
• Start date: February 20, 2015
• Est. completion date: October 23, 2018

Study information

• Verified date: May 2019
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 23, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has completed participation in one of the ONC201 protocols, has not shown tumor progression while on study treatment, and has tolerated the study drug without unacceptable toxicities

• Patient has not met criteria for withdrawal from the base protocol

• Patient is willing to comply with protocol requirements and procedures, and keep scheduled study visits

• Patient agrees to practice effective contraception during the entire study period unless documentation of infertility exists

• Patient is able to understand and is willing to sign the informed consent form

Exclusion Criteria:

• Patient is receiving concomitant standard and/or investigational anticancer therapy; local palliative radiotherapy is permissible upon discussion with the principal investigator

• Patient has alcohol or substance abuse which, in the opinion of the investigator, would interfere with compliance or safety

• Patient has any condition or laboratory abnormality which, in the opinion of the investigator, would pose additional risk in administering the study drug to the patient

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor

Intervention

Drug:
• Oral ONC201
Given PO

Other:
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Oncoceutics, Inc., Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in serum biomarkers of therapeutic response	Descriptive statistics will be provided.	Baseline to up to 4 weeks after end of study treatment
Other	Changes in molecular targets of oral ONC201	Descriptive statistics will be provided.	Baseline to up to 4 weeks after end of study treatment
Primary	Incidence of adverse experiences from oral ONC201 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	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.	Up to 4 weeks after end of study treatment
Secondary	Frequency of toxicities associated with ONC201		Up to 4 weeks after end of study treatment
Secondary	Response rate of oral ONC201 in patients with advanced solid tumors		At 3 months
Secondary	Pharmacokinetic parameters	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.	Up to 4 weeks of therapy
Secondary	Clinical benefit rate (stable disease and partial disease)		At 3 months
Secondary	Time to progressive disease	Descriptive statistics on continuous data will include means, medians, standard deviations, and ranges will be provided to estimate clinical benefit rate.	Up to 4 weeks after end of study treatment