Clinical trial NCT02324621: Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors
Official title: A Continuation Clinical Trial of Every Three-Week Dosing of Oral ONC201 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor
Keywords: protocol specific
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
name: Oncoceutics, Inc.
First posted: 2014-12-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of adverse experiences from oral ONC201 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
timeFrame: Up to 4 weeks after end of study treatment
Secondary outcomes:
measure: Frequency of toxicities associated with ONC201
timeFrame: Up to 4 weeks after end of study treatment
measure: Response rate of oral ONC201 in patients with advanced solid tumors
timeFrame: At 3 months
measure: Pharmacokinetic parameters
timeFrame: Up to 4 weeks of therapy
measure: Clinical benefit rate (stable disease and partial disease)
timeFrame: At 3 months
measure: Time to progressive disease
timeFrame: Up to 4 weeks after end of study treatment
Other outcomes:
measure: Changes in serum biomarkers of therapeutic response
timeFrame: Baseline to up to 4 weeks after end of study treatment
measure: Changes in molecular targets of oral ONC201
timeFrame: Baseline to up to 4 weeks after end of study treatment
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Jyoti Malhotra
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.