11 terminated, 6 completed, 5 recruiting, 4 withdrawn. 17 Phase 2, 13 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 17 | Terminated 10, Withdrawn 3, Completed 2, Recruiting 2 |
| Phase 1 | 13 | Terminated 6, Completed 4, Withdrawn 2, Recruiting 1 |
| Phase 3 | 2 | Recruiting 2 |
Follow TIC10 compound: new trials by email Literature Review of TIC10 compound trials Research Report on TIC10 compound
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of ONC201 for Refractory Meningioma ONC201 - Meningioma, Refractory Meningioma | Phase 2 | Withdrawn | University of Nebraska | 2026-12-01 | 2026-01-26 | |
| A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma ONC201 - Glioblastoma | Phase 2 | Withdrawn | Masonic Cancer Center, University of Minnesota | 2024-06-28 | 2023-11-24 | |
| ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer Atezolizumab, ONC201 - Endometrial Cancer, Metastasis | Phase 1 | Recruiting | UNC Lineberger Comprehensive Cancer Center | 58 | 2023-10-23 | 2026-01-29 |
| ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) Dordaviprone (ONC201), Dordaviprone (ONC201) + Placebo, Placebo - H3 K27M, Glioma | Phase 3 | Recruiting | Jazz Pharmaceuticals | 510 | 2023-01-23 | 2026-04-16 |
| Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 Everolimus, ONC201, Radiotherapy - Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant | Phase 3 | Recruiting | Gustave Roussy, Cancer Campus, Grand Paris | 433 | 2022-09-29 | 2026-10-21 |
| Combination Therapy for the Treatment of Diffuse Midline Gliomas ONC201, Radiation Therapy, Paxalisib - Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant | Phase 2 | Recruiting | University of California, San Francisco | 360 | 2021-10-20 | 2026-06-26 |
| ONC201 and Radiation Therapy Before Surgery for the Treatment of Recurrent Glioblastoma Akt/ERK Inhibitor ONC201, Radiation Therapy, Resection - Recurrent Glioblastoma, Recurrent Gliosarcoma | Phase 1 | Withdrawn | Jonsson Comprehensive Cancer Center | 2021-05-01 | 2021-05-12 | |
| ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer Akt/ERK Inhibitor ONC201, Paclitaxel, Questionnaire Administration - Malignant Ovarian Epithelial Tumor, Platinum-Resistant Fallopian Tube Carcinoma | Phase 2 | Recruiting | Ira Winer | 62 | 2020-01-21 | 2026-06-17 |
| BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC Dose level 1 ONC201 625mg, Dose level 2 ONC201 500mg, Dose level 3 ONC201 375mg - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Terminated | Brown University | 13 | 2019-11-15 | 2023-02-17 |
| ONC-201 Maintenance Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome After Stem Cell Transplant ONC-201 - Acute Myeloid Leukemia, Myelodysplastic Syndromes | Phase 1 | Completed | University of Nebraska | 20 | 2019-07-30 | 2026-05-28 |
| ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer Akt/ERK Inhibitor ONC201, Methionine-Restricted Diet - Triple Negative Breast Cancer | Phase 2 | Terminated | University of Wisconsin, Madison | 4 | 2018-11-13 | 2022-03-10 |
| Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma ONC201, Ixazomib, Dexamethasone - Multiple Myeloma | Phase 1 / Phase 2 | Terminated | Ajai Chari | 5 | 2018-03-26 | 2020-05-29 |
| ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer Dordaviprone (ONC201) - Endometrial Cancer Recurrent | Phase 2 | Terminated | Jazz Pharmaceuticals | 27 | 2018-03-21 | 2024-12-24 |
| ONC201 in Pediatric H3 K27M Gliomas Dordaviprone (ONC201) - Diffuse Intrinsic Pontine Glioma, Glioma, Malignant | Phase 1 | Terminated | Jazz Pharmaceuticals | 134 | 2018-01-25 | 2025-02-14 |
| ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma ONC201 - Triple Negative Breast Cancer, Endometrial Cancer | Phase 2 | Completed | National Cancer Institute (NCI) | 30 | 2018-01-17 | 2022-08-23 |
| ONC201 in Adults With Recurrent H3 K27M-mutant Glioma Dordaviprone (ONC201) - Glioma | Phase 2 | Terminated | Jazz Pharmaceuticals | 73 | 2017-10-30 | 2025-07-28 |
| Phase 2 Study of ONC201 in Neuroendocrine Tumors ONC201 - Recurrent Neuroendocrine Tumor, Metastatic Neuroendocrine Tumor | Phase 2 | Completed | Peter Anderson | 30 | 2017-08-02 | 2024-11-26 |
| Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer ONC201 - Endometrial Cancer | Phase 2 | Terminated | Fox Chase Cancer Center | 19 | 2017-06-08 | 2026-10-14 |
| Oral ONC201 in Relapsed/Refractory Multiple Myeloma ONC201, Dexamethasone - Multiple Myeloma | Phase 1 / Phase 2 | Terminated | Jazz Pharmaceuticals | 17 | 2017-04-19 | 2024-07-03 |
| Oral ONC201 in Adult Recurrent Glioblastoma Dordaviprone (ONC201) - Glioblastoma, Diffuse Midline Glioma | Phase 2 | Terminated | Jazz Pharmaceuticals | 84 | 2016-01-01 | 2024-12-24 |
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Glioma (6) · Diffuse Intrinsic Pontine Glioma (3) · Endometrial Neoplasms (3) · Glioblastoma (3) · Multiple Myeloma (3) · Neoplasm Metastasis (3) · Leukemia, Myeloid, Acute (2) · Myelodysplastic Syndromes (2) · Triple Negative Breast Neoplasms (2) · Breast Neoplasms, Male (1) · Carcinosarcoma (1) · Colonic Neoplasms (1) · Colorectal Neoplasms (1) · Disease (1) · Fallopian Tube Neoplasms (1)
Jazz Pharmaceuticals (10) · Fox Chase Cancer Center (2) · M.D. Anderson Cancer Center (2) · Rutgers, The State University of New Jersey (2) · University of Nebraska (2) · Ajai Chari (1) · Brown University (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · Ira Winer (1) · Jonsson Comprehensive Cancer Center (1) · Masonic Cancer Center, University of Minnesota (1) · National Cancer Institute (NCI) (1) · Peter Anderson (1) · UNC Lineberger Comprehensive Cancer Center (1) · University of California, San Francisco (1)
United States (27) · Australia (2) · Denmark (2) · Israel (2) · Netherlands (2) · Spain (2) · Switzerland (2) · Argentina (1) · Austria (1) · Belgium (1) · Brazil (1) · Canada (1) · Finland (1) · France (1) · Germany (1)
Allen Mellemed, MD (2) · Jyoti Malhotra (2) · Ajai Chari, MD (1) · Anthony Olszanski, MD (1) · Gautam Borthakur (1) · Gina Mantia-Smaldone, MD (1) · Ira Winer, M.D. (1) · Jason Faris, MD (1) · Kari Wisinski, MD (1) · Nicole Shonka, MD (1) · Peter M Anderson, MD, PhD (1) · Phioanh Nghiemphu (1) · Sabine Mueller, MD, PhD (1)
PMID 38335473, PMID 31118108, PMID 31456142, PMID 34003586, PMID 35022321, PMID 35137228, PMID 35157764, PMID 35414025, PMID 37195023, PMID 37279797, PMID 42359621
P30CA072720 (2), 2014 (1), 2023 (1), P50CA211015 (1), R01NS124607 (1), R21CA267584 (1)