Therapy Detail

Request Content

Contact

Missing content? – Request curation!

Request curation for specific Genes, Variants, or PubMed publications.

Have questions, comments, or suggestions? - Let us know!

Email us at : ckbsupport@genomenon.com

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).

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 )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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 )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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

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 )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03099499 Phase II Dordaviprone Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer Terminated USA 0
NCT02525692 Phase II Dordaviprone Oral ONC201 in Recurrent GBM, H3 K27M Glioma, and Midline Glioma Terminated 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
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
NCT03932643 Phase I Dordaviprone ONC-201 Maintenance Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome After Stem Cell Transplant Completed USA 0
NCT04854044 Phase I Dordaviprone ONC201 and Radiation Therapy Before Surgery for the Treatment of Recurrent 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
NCT03295396 Phase II Dordaviprone ONC201 in Adults With Recurrent H3 K27M-mutant Glioma Terminated USA 0
NCT03034200 Phase II Dordaviprone Phase 2 Study of ONC201 in Neuroendocrine Tumors Completed USA 0
NCT03416530 Phase I Dordaviprone ONC201 in Pediatric H3 K27M Gliomas Terminated USA 0
NCT03485729 Phase II Dordaviprone ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer 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
NCT02863991 Phase II Dordaviprone Oral ONC201 in Relapsed/Refractory Multiple Myeloma Terminated USA 0
NCT03134131 Expanded access Dordaviprone Expanded Access Program for ONC201 to Treat Recurrent Histone H3 Mutant Glioma No longer available 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
NCT02038699 Phase Ib/II Dordaviprone A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced Cancer Withdrawn USA 0
NCT04629209 Phase II Dordaviprone A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma Withdrawn USA 0
NCT06012929 Phase I Dordaviprone A Study of ONC201 for Refractory Meningioma Suspended USA 0
NCT02250781 Phase I Dordaviprone Akt/ERK Inhibitor ONC201 in Treating Patients With Advanced Solid Tumors Completed USA 0
NCT02324621 Phase I Dordaviprone Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors Completed 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
NCT03394027 Phase II Dordaviprone ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma 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


Additional content available in Icon for CKB-BoostCKB BOOST