Studies
| Study First Submitted Date | 2021-12-01 |
| Study First Posted Date | 2022-05-26 |
| Last Update Posted Date | 2022-05-26 |
| Verification Month Year | May 2022 |
| Verification Date | 2022-05-31 |
| Last Update Posted Date | 2022-05-26 |
Facilities
| Sequence: | 201170500 | Sequence: | 201170501 | Sequence: | 201170502 | Sequence: | 201170503 | Sequence: | 201170504 | Sequence: | 201170505 | Sequence: | 201170506 | Sequence: | 201170507 | Sequence: | 201170508 | Sequence: | 201170509 |
| Name | University of California San Francisco | Name | Children's Hospital Colorado | Name | Children's National Medical Center | Name | Children's Healthcare of Atlanta | Name | University of Michigan | Name | University of Nebraska Medical Center | Name | Albany Medical Center | Name | NYU Langone Health | Name | Stephen Hassenfeld Children's Center for Cancer and Blood Disorders (NYU) | Name | University of Rochester Medical Center |
| City | San Francisco | City | Aurora | City | Washington | City | Atlanta | City | Ann Arbor | City | Omaha | City | Albany | City | New York | City | New York | City | Rochester |
| State | California | State | Colorado | State | District of Columbia | State | Georgia | State | Michigan | State | Nebraska | State | New York | State | New York | State | New York | State | New York |
| Zip | 94143 | Zip | 80045 | Zip | 20010 | Zip | 30342 | Zip | 48109 | Zip | 68198 | Zip | 12208 | Zip | 10016 | Zip | 10016 | Zip | 14642 |
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
| Sequence: | 96532117 | Sequence: | 96532118 |
| Mesh Term | TIC10 compound | Mesh Term | Antineoplastic Agents |
| Downcase Mesh Term | tic10 compound | Downcase Mesh Term | antineoplastic agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52467249 |
| Name | Glioma |
| Downcase Name | glioma |
Id Information
| Sequence: | 40370907 |
| Id Source | org_study_id |
| Id Value | ONC016 |
Countries
| Sequence: | 42806216 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52777602 |
| Intervention Type | Drug |
| Name | ONC201 |
| Description | ONC201 is an oral, small molecule selective antagonist of DRD2 |
Browse Conditions
| Sequence: | 194617921 | Sequence: | 194617922 | Sequence: | 194617923 | Sequence: | 194617924 | Sequence: | 194617925 | Sequence: | 194617926 | Sequence: | 194617927 | Sequence: | 194617928 | Sequence: | 194617929 | Sequence: | 194617930 | Sequence: | 194617931 | Sequence: | 194617932 | Sequence: | 194617933 | Sequence: | 194617934 | Sequence: | 194617935 | Sequence: | 194617936 | Sequence: | 194617937 | Sequence: | 194617938 |
| Mesh Term | Glioma | Mesh Term | Diffuse Intrinsic Pontine Glioma | Mesh Term | Neoplasms, Neuroepithelial | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms, Nerve Tissue | Mesh Term | Brain Stem Neoplasms | Mesh Term | Infratentorial Neoplasms | Mesh Term | Brain Neoplasms | Mesh Term | Central Nervous System Neoplasms | Mesh Term | Nervous System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases |
| Downcase Mesh Term | glioma | Downcase Mesh Term | diffuse intrinsic pontine glioma | Downcase Mesh Term | neoplasms, neuroepithelial | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms, nerve tissue | Downcase Mesh Term | brain stem neoplasms | Downcase Mesh Term | infratentorial neoplasms | Downcase Mesh Term | brain neoplasms | Downcase Mesh Term | central nervous system neoplasms | Downcase Mesh Term | nervous system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48594400 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Chimerix |
Eligibilities
| Sequence: | 30935213 |
| Minimum Age | 6 Months |
| Maximum Age | 18 Years |
| Criteria | Inclusion Criteria: Patient with DIPG who failed at least one line of prior therapy such as focal radiation therapy Patient must be > than 6 months and < 18 years of age. Confirmed evidence of disease progression from immediately prior therapy or refractory to the immediately prior treatment. Karnofsky/Lansky performance status ≥ 50. Adequate organ and marrow function as defined below: Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment (cycle 1 day 1, C1D1) ________________________________________________________________________________ CONFIDENTIAL Page 3 of 45 Hemoglobin>8.0 mg/dL without red blood cell transfusion ≤ 3 days prior to C1D1 Total serum bilirubin<1.5 X upper limit of normal (ULN) AST (SGOT)/ALT (SGPT)≤2 X ULN;; ≤ 5 X ULN if there is liver involvement secondary to tumor Serum creatinine≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2) Ability to understand and the willingness to sign a written informed consent document by the patient or their legal guardian. If patient is of child–bearing age, 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. Patient must be able to swallow capsules and retain orally administered medication. Exclusion Criteria: Body weight >10Kg. Known active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV). Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)–related illness. Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L). Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. 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. 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. |
| Adult | True |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 254223063 |
| Number Of Facilities | 10 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 6 |
| Maximum Age Num | 18 |
| Minimum Age Unit | Months |
| Maximum Age Unit | Years |
Responsible Parties
| Sequence: | 29047564 |
| Responsible Party Type | Sponsor |