6 terminated, 4 completed, 4 recruiting, 4 withdrawn. 13 Phase 2, 9 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Terminated 6, Withdrawn 3, Completed 2, Recruiting 2 |
| Phase 1 | 9 | Terminated 4, Completed 2, Withdrawn 2, Recruiting 1 |
| Phase 3 | 1 | Recruiting 1 |
Follow ONC201: new trials by email Literature Review of ONC201 trials Research Report on ONC201
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| A Study of ONC201 for Refractory Meningioma ONC201 - Meningioma, Refractory Meningioma | Phase 2 | Withdrawn | University of Nebraska | 2026-12-01 | 2026-01-26 | |
| A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma ONC201 - Glioblastoma | Phase 2 | Withdrawn | Masonic Cancer Center, University of Minnesota | 2024-06-28 | 2023-11-24 | |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 |
| 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Akt/ERK Inhibitor ONC201, Radiation Therapy, Resection - Recurrent Glioblastoma, Recurrent Gliosarcoma | Phase 1 | Withdrawn | Jonsson Comprehensive Cancer Center | 2021-05-01 | 2021-05-12 | |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 |
| 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/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 |
| 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 |
| ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome Akt/ERK Inhibitor ONC201, Venetoclax - Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 58 | 2015-11-03 | 2026-08-20 |
| Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Akt/ERK Inhibitor ONC201, Laboratory Biomarker Analysis, Pharmacological Study - Central Nervous System Lymphoma, Gastric Mantle Cell Lymphoma | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 16 | 2015-11-03 | 2022-04-04 |
| Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors Oral ONC201, pharmacological study, laboratory biomarker analysis - Unspecified Adult Solid Tumor | Phase 1 | Completed | Rutgers, The State University of New Jersey | 26 | 2015-02-20 | 2019-05-22 |
| Oral ONC201 in Treating Patients With Advanced Solid Tumors Oral ONC201 - Solid Tumors | Phase 1 | Completed | Rutgers, The State University of New Jersey | 58 | 2015-01-12 | 2019-05-22 |
| A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced Cancer ONC201 - Advanced Glioblastoma, Advanced Colorectal Cancer | Phase 1 / Phase 2 | Withdrawn | Jazz Pharmaceuticals | 2014-01-01 | 2021-04-30 | |
| Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline High Grade Gliomas ONC201 - Glioma | No longer available | Jazz Pharmaceuticals | 2022-03-14 | |||
| Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas ONC201 - Glioma | No longer available | Jazz Pharmaceuticals | 2022-05-26 |
Endometrial Neoplasms (3) · Diffuse Intrinsic Pontine Glioma (2) · Glioblastoma (2) · Glioma (2) · Multiple Myeloma (2) · Neoplasm Metastasis (2) · Triple Negative Breast Neoplasms (2) · Breast Neoplasms, Male (1) · Carcinosarcoma (1) · Disease (1) · Fallopian Tube Neoplasms (1) · Gliosarcoma (1) · Leukemia, Myeloid, Acute (1) · Lymphoma, Mantle-Cell (1) · Lymphoma, Non-Hodgkin (1)
Jazz Pharmaceuticals (4) · M.D. Anderson Cancer Center (2) · Rutgers, The State University of New Jersey (2) · Ajai Chari (1) · Fox Chase Cancer Center (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) · University of Nebraska (1) · University of Wisconsin, Madison (1)
United States (18) · Australia (1) · Belgium (1) · Denmark (1) · Finland (1) · France (1) · Greece (1) · Israel (1) · Netherlands (1) · New Zealand (1) · Norway (1) · Spain (1) · Sweden (1) · Switzerland (1)
Jyoti Malhotra (2) · Ajai Chari, 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) · Stanley Lipkowitz, M.D. (1) · Victoria Bae-Jump, MD, PhD (1)
PMID 31118108, PMID 38335473, PMID 35022321, PMID 35157764, PMID 35414025, PMID 37195023, PMID 37279797
P30CA072720 (2), 2014 (1), 2023 (1), P50CA211015 (1), R01NS124607 (1), R21CA267584 (1)