Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02324621
Other study ID # 051407
Secondary ID NCI-2014-0204305
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01450384 - Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00477607 - Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin Phase 2/Phase 3
Completed NCT02049593 - PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid Tumors Phase 1
Terminated NCT00938457 - Stereotactic Radiation Therapy in Treating Patients With Liver Metastases Phase 1/Phase 2
Suspended NCT01843413 - Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases N/A
Withdrawn NCT03789773 - Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy N/A
Completed NCT00390156 - Imatinib, Bevacizumab, and Cyclophosphamide in Patients With Refractory Metastatic Solid Tumors Phase 1
Completed NCT00037804 - Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction Phase 1