11 completed, 3 terminated, 2 withdrawn, 1 recruiting. 11 Phase 1, 10 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 7, Terminated 3, Withdrawn 1 |
| Phase 2 | 10 | Completed 6, Withdrawn 2, Recruiting 1, Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) Tenalisib - Triple Negative Breast Cancer (TNBC) | Phase 2 | Recruiting | Rhizen Pharmaceuticals SA | 40 | 2024-03-04 | 2025-12-02 |
| Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RP7214 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia RP7214 - Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia | Phase 1 / Phase 2 | Withdrawn | Rhizen Pharmaceuticals SA | 2023-01-01 | 2022-10-31 | |
| Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL Tenalisib - Peripheral T Cell Lymphoma | Phase 2 | Withdrawn | Rhizen Pharmaceuticals SA | 2023-01-01 | 2022-10-17 | |
| Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer Tenalisib 800mg, Tenalisib 1200mg - Locally Advanced Breast Cancer, Metastatic Breast Cancer | Phase 2 | Completed | Rhizen Pharmaceuticals SA | 40 | 2021-10-13 | 2024-08-13 |
| Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors RP12146 - Solid Tumor, Extensive-stage Small-cell Lung Cancer | Phase 1 | Completed | Rhizen Pharmaceuticals SA | 23 | 2021-10-05 | 2024-09-19 |
| Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. RP7214 + Standard of care (SOC), Placebo + Standard of care (SOC) - SARS-CoV-2 Infection | Phase 2 | Completed | Rhizen Pharmaceuticals SA | 163 | 2021-09-20 | 2022-04-21 |
| A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects RP7214, Placebo - Healthy Volunteers | Phase 1 | Completed | Rhizen Pharmaceuticals SA | 42 | 2020-12-29 | 2021-08-18 |
| Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Tenalisib - Leukemia, Lymphocytic, Chronic, B-Cell | Phase 2 | Completed | Rhizen Pharmaceuticals SA | 21 | 2019-11-28 | 2024-08-13 |
| Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma Tenalisib, Romidepsin - T Cell Lymphoma | Phase 1 / Phase 2 | Completed | Rhizen Pharmaceuticals SA | 33 | 2019-03-12 | 2022-10-28 |
| Compassionate Use Study of Tenalisib (RP6530) Tenalisib - Hematological Malignancies | Phase 1 / Phase 2 | Completed | Rhizen Pharmaceuticals SA | 17 | 2018-11-28 | 2024-05-08 |
| Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL) Tenalisib, - Non Hodgkin Lymphoma | Phase 2 | Completed | Rhizen Pharmaceuticals SA | 20 | 2018-11-25 | 2021-08-12 |
| Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL Tenalisib, Pembrolizumab - Classical Hodgkin Lymphoma | Phase 1 | Terminated | Rhizen Pharmaceuticals SA | 2 | 2018-07-18 | 2019-12-27 |
| Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas RP4010 - Lymphoma | Phase 1 | Terminated | Rhizen Pharmaceuticals SA | 21 | 2017-05-11 | 2019-12-27 |
| Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals RP3128, Placebo - Healthy Volunteers, Asthma | Phase 1 / Phase 2 | Terminated | Rhizen Pharmaceuticals SA | 57 | 2016-11-03 | 2019-10-04 |
| To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers RP6530 - Healthy | Phase 1 | Completed | Rhizen Pharmaceuticals SA | 18 | 2016-02-01 | 2017-11-28 |
| Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma RP6530 - Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous | Phase 1 | Completed | Rhizen Pharmaceuticals SA | 58 | 2015-09-01 | 2020-01-13 |
| Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies RP6530 - Lymphoma, B-Cell, T-Cell Lymphoma | Phase 1 | Completed | Rhizen Pharmaceuticals SA | 35 | 2013-11-01 | 2016-06-24 |
Breast Neoplasms (2) · Leukemia, Myeloid, Acute (2) · Lymphoma, Non-Hodgkin (2) · Lymphoma, T-Cell (2) · Lymphoma, T-Cell, Cutaneous (2) · Lymphoma, T-Cell, Peripheral (2) · Asthma (1) · COVID-19 (1) · Fasting (1) · Hematologic Neoplasms (1) · Hodgkin Disease (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Leukemia, Myelomonocytic, Chronic (1) · Lymphoma (1) · Lymphoma, B-Cell (1)
tenalisib (11) · RP7214 (3) · Phosphatidylinositol 3-Kinases (1) · RP3128 (1) · RP4010 (1) · Standard of Care (1) · pembrolizumab (1) · romidepsin (1)
United States (8) · Georgia (3) · Poland (3) · Australia (2) · Canada (2) · India (2) · Bulgaria (1) · Czechia (1) · France (1) · Italy (1)
Auris Huen, MD (1) · Carmelo Carlo-stella, MD (1) · Eric Sicard, M.D (1) · Richard Delarue, MD (1)