We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Expanded Access Program for ONC201 to Treat Recurrent Histone H3 K27M Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03134131
Recruitment Status : Available
First Posted : April 28, 2017
Last Update Posted : November 13, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this expanded access program is to provide ONC201 on a single patient compassionate use basis to eligible adult subjects with recurrent glioma that exhibits a missense histone H3 mutation .

Condition or disease Intervention/treatment
Glioma Drug: ONC201

Study Design

Study Type : Expanded Access

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Confirmed evidence of glioma with disease progression from immediately prior therapy or refractory to the immediately prior treatment.
  2. Evidence of missense histone H3 tumor mutation detected by a CLIA assay, either by IHC or DNA sequencing, that includes but is not restricted to K27M, G34R, and G34V in H3.3.
  3. Male or Female age ≥18 years.
  4. Karnofsky Performance Status (KPS) ≥ 50%
  5. ECOG performance status ≤ 2.
  6. Adequate organ and marrow function as defined below:

    1. Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment.
    2. Hemoglobin >8.0 mg/dL without red blood cell transfusion ≤ 3 days prior to treatment.
    3. Total serum bilirubin <1.5 X upper limit of normal (ULN)
    4. AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if there is liver involvement secondary to tumor.
    5. Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2)
  7. Ability to understand and the willingness to sign a written informed consent document.
  8. Ability to swallow capsules
  9. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.

Exclusion Criteria:

  1. Known active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV).
  2. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  3. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
  4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134131

Contact: Clinical Operations Oncoceutics 1-888-ONCORXS ext 1 info@oncoceutics.com

United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Oncoceutics, Inc.
More Information

Responsible Party: Oncoceutics, Inc.
ClinicalTrials.gov Identifier: NCT03134131     History of Changes
Other Study ID Numbers: ONC011
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue