Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors

NCT02324621 | Completed Phase 1

• 3 other identifiers: 051407NCI-2014-02043P30CA072720
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor

Keywords

protocol specific

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Frequency of toxicities associated with ONC201

  Up to 4 weeks after end of study treatment

• Response rate of oral ONC201 in patients with advanced solid tumors

  At 3 months

• Pharmacokinetic parameters

  Up to 4 weeks of therapy

• Clinical benefit rate (stable disease and partial disease)

  At 3 months

• Time to progressive disease

  Up to 4 weeks after end of study treatment

Other Outcomes (2)

• Changes in serum biomarkers of therapeutic response

  Baseline to up to 4 weeks after end of study treatment

• Changes in molecular targets of oral ONC201

  Baseline to up to 4 weeks after end of study treatment

Study Arms (1)

Treatment (oral ONC201)

EXPERIMENTAL

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; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

Oral ONC201 DRUG

Given PO

Also known as: ONC201, TIC10

Treatment (oral ONC201)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (oral ONC201)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (oral ONC201)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator
• Oncoceutics, Inc.: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Related Publications (1)

• Stein MN, Malhotra J, Tarapore RS, Malhotra U, Silk AW, Chan N, Rodriguez L, Aisner J, Aiken RD, Mayer T, Haffty BG, Newman JH, Aspromonte SM, Bommareddy PK, Estupinian R, Chesson CB, Sadimin ET, Li S, Medina DJ, Saunders T, Frankel M, Kareddula A, Damare S, Wesolowsky E, Gabel C, El-Deiry WS, Prabhu VV, Allen JE, Stogniew M, Oster W, Bertino JR, Libutti SK, Mehnert JM, Zloza A. Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration. J Immunother Cancer. 2019 May 22;7(1):136. doi: 10.1186/s40425-019-0599-8.

  PMID: 31118108 DERIVED

MeSH Terms

Interventions

TIC10 compound

Study Officials

• Jyoti Malhotra

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: December 24, 2014
• Study Start: February 20, 2015
• Primary Completion: October 18, 2018
• Study Completion: October 23, 2018
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

US (1)