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A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced Cancer

NCT02038699 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-04-30

No results posted yet for this study

Summary

ONC201 is a new potential drug that kills cancer cells but not normal cells in laboratory studies. This clinical trial will be the first evaluation of ONC201 in humans and will enroll patients with advanced cancer. This trial includes a phase I portion that will evaluate the safety of ONC201 and the recommended dose for the phase II portion. The phase II portion will evaluate the initial efficacy profile of ONC201 in select types of cancer.

Conditions

Interventions

DRUG

ONC201

ONC201 capsules will be administered orally once every three weeks with flat dosing. Dosage will be given according to a modified Fibonacci sequence with the anticipated starting dose being 125 mg.

Sponsors & Collaborators

Principal Investigators

  • Jason Faris, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02038699 on ClinicalTrials.gov