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ONC201 and Radiation Therapy Before Surgery for the Treatment of Recurrent Glioblastoma

NCT04854044 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-05-12

No results posted yet for this study

Summary

This phase I trial studies the effects of ONC201 in combination with standard of care radiation therapy in treating patients with glioblastoma that has come back (recurrent). ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy photons to kill tumors cells and shrink tumors. Giving ONC201 in combination with radiation therapy may help treat patients with recurrent glioblastoma.

Conditions

  • Recurrent Glioblastoma
  • Recurrent Gliosarcoma
  • Recurrent Supratentorial Glioblastoma
  • Supratentorial Gliosarcoma

Interventions

DRUG

Akt/ERK Inhibitor ONC201

Given orally

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Resection

Undergo surgical resection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Oncoceutics, Inc.

    collaborator INDUSTRY

  • University of California, Los Angeles

    collaborator OTHER

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Phioanh Nghiemphu · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2025-07-01
Completion
2026-07-01
FDA Drug
Yes

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 NCT04854044 on ClinicalTrials.gov