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Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02324621
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Oncoceutics, Inc.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

October 28, 2014
December 24, 2014
August 9, 2018
February 2015
March 2019   (Final data collection date for primary outcome measure)
Incidence of adverse experiences from oral ONC201 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 4 weeks after end of study treatment ]
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.
Same as current
Complete list of historical versions of study NCT02324621 on ClinicalTrials.gov Archive Site
  • Frequency of toxicities associated with ONC201 [ Time Frame: Up to 4 weeks after end of study treatment ]
  • Response rate of oral ONC201 in patients with advanced solid tumors [ Time Frame: At 3 months ]
  • Pharmacokinetic parameters [ Time Frame: Up to 4 weeks of therapy ]
    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.
  • Clinical benefit rate (stable disease and partial disease) [ Time Frame: At 3 months ]
  • Time to progressive disease [ Time Frame: Up to 4 weeks after end of study treatment ]
    Descriptive statistics on continuous data will include means, medians, standard deviations, and ranges will be provided to estimate clinical benefit rate.
Same as current
  • Changes in serum biomarkers of therapeutic response [ Time Frame: Baseline to up to 4 weeks after end of study treatment ]
    Descriptive statistics will be provided.
  • Changes in molecular targets of oral ONC201 [ Time Frame: Baseline to up to 4 weeks after end of study treatment ]
    Descriptive statistics will be provided.
Same as current
 
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
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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Unspecified Adult Solid Tumor
  • Drug: Oral ONC201
    Given PO
    Other Names:
    • ONC201
    • TIC10
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: Oral ONC201
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Clinical Trials Office 732-235-7521
United States
 
 
NCT02324621
051407
NCI-2014-02043 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
051407 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
  • Oncoceutics, Inc.
Principal Investigator: Jyoti Malhotra Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP