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Therapy Name Dordaviprone
Synonyms
Therapy Description

Modeyso (dordaviprone) is a small molecule dopamine receptor D2 (DRD2) antagonist (PMID: 31702782) that induces TRAIL signaling (PMID: 23390247) and activates the mitochondrial protease, ClpP (PMID: 31021596), leading to anti-tumor activity (PMID: 31456142, PMID: 31702782). Modeyso (dordaviprone) is FDA-approved for use in adult and pediatric patients 1 year and older with diffuse midline glioma harboring an H3 K27M mutation who progressed on prior therapies (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Dordaviprone Modeyso TIC-10|TIC10|ONC201 Akt Inhibitor (Pan) 22 ERK Inhibitor (pan) 21 Modeyso (dordaviprone) is a small molecule dopamine receptor D2 (DRD2) antagonist (PMID: 31702782) that induces TRAIL signaling (PMID: 23390247) and activates the mitochondrial protease, ClpP (PMID: 31021596), leading to anti-tumor activity (PMID: 31456142, PMID: 31702782). Modeyso (dordaviprone) is FDA-approved for use in adult and pediatric patients 1 year and older with diffuse midline glioma harboring an H3 K27M mutation who progressed on prior therapies (FDA.gov).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04617002 Expanded access Dordaviprone Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas Approved for marketing USA 0
NCT03134131 Expanded access Dordaviprone Expanded Access Program for ONC201 to Treat Recurrent Histone H3 Mutant Glioma No longer available USA 0
NCT03034200 Phase II Dordaviprone Phase 2 Study of ONC201 in Neuroendocrine Tumors Completed USA 0
NCT06012929 Phase I Dordaviprone A Study of ONC201 for Refractory Meningioma Suspended USA 0
NCT02324621 Phase I Dordaviprone Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors Completed USA 0
NCT02038699 Phase Ib/II Dordaviprone A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced Cancer Withdrawn USA 0
NCT03485729 Phase II Dordaviprone ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer Terminated USA 0
NCT03932643 Phase I Dordaviprone ONC-201 Maintenance Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome After Stem Cell Transplant Completed USA 0
NCT02250781 Phase I Dordaviprone Akt/ERK Inhibitor ONC201 in Treating Patients With Advanced Solid Tumors Completed USA 0
NCT05476939 Phase III Everolimus Dordaviprone Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (BIOMEDE 2) Recruiting SWE | FRA | ESP | DNK 0
NCT03295396 Phase II Dordaviprone ONC201 in Adults With Recurrent H3 K27M-mutant Glioma Terminated USA 0
NCT03416530 Phase I Dordaviprone ONC201 in Pediatric H3 K27M Gliomas Terminated USA 0
NCT02525692 Phase II Dordaviprone Oral ONC201 in Recurrent GBM, H3 K27M Glioma, and Midline Glioma Terminated USA 0
NCT05580562 Phase III Dordaviprone ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) (ACTION) Recruiting USA | NLD | ITA | ISR | GBR | ESP | DNK | DEU | CHE | CAN | BRA | AUT | AUS | ARG 4
NCT03099499 Phase II Dordaviprone Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer Terminated USA 0
NCT02392572 Phase Ib/II Dordaviprone ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome Recruiting USA 0
NCT04629209 Phase II Dordaviprone A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma Withdrawn USA 0
NCT02420795 Phase Ib/II Dordaviprone Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma Terminated USA 0
NCT04854044 Phase I Dordaviprone ONC201 and Radiation Therapy Before Surgery for the Treatment of Recurrent Glioblastoma Withdrawn USA 0
NCT02609230 Phase I Dordaviprone A Dose-Escalation Study of Onc201 Administered Every One or Three Weeks in Advanced Solid Tumors and Multiple Myeloma Completed USA 0
NCT03394027 Phase II Dordaviprone ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma Completed USA 0
NCT02863991 Phase II Dordaviprone Oral ONC201 in Relapsed/Refractory Multiple Myeloma Terminated USA 0
NCT03733119 Phase II Dordaviprone ONC201 With and Without Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer Terminated USA 0
NCT05630794 Phase I Dordaviprone Testing for Safety and Colorectal Cancer Preventive Effects of ONC201 Recruiting USA 0


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