Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT02324621
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 26
- Starts
- 2015-02-20
- Expected to finish
- 2018-10-23
- Last updated by the study team
- 2019-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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