Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2018-10-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Oncoceutics, Inc.; Rutgers Cancer Institute of New Jersey
• Treatments: TIC10 compound

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