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Trial record 25 of 200 for:    Oral Cancer | Recruiting Studies | NIH

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 : February 5, 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

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor Drug: Oral ONC201 Other: pharmacological study Other: laboratory biomarker analysis Phase 1

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Continuation Clinical Trial of Every Three-Week Dosing of Oral ONC201 in Patients With Advanced Solid Tumors
Study Start Date : February 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
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
Given PO
Other Names:
  • ONC201
  • TIC10

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Frequency of toxicities associated with ONC201 [ Time Frame: Up to 4 weeks after end of study treatment ]
  2. Response rate of oral ONC201 in patients with advanced solid tumors [ Time Frame: At 3 months ]
  3. 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.

  4. Clinical benefit rate (stable disease and partial disease) [ Time Frame: At 3 months ]
  5. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324621


Contacts
Contact: Clinical Trials Office 732-235-7521

Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Jyoti Malhotra    732-235-7521    jyoti.malhotra@rutgers.edu   
Principal Investigator: Jyoti Malhotra         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Oncoceutics, Inc.
Investigators
Principal Investigator: Jyoti Malhotra Rutgers Cancer Institute of New Jersey

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02324621     History of Changes
Other Study ID Numbers: 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 )
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Rutgers, The State University of New Jersey:
protocol specific