9 completed, 7 terminated. 11 Phase 2, 5 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Terminated 6, Completed 5 |
| Phase 1 | 5 | Completed 4, Terminated 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
Follow plitidepsin: new trials by email Literature Review of plitidepsin trials Research Report on plitidepsin
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 |
|---|---|---|---|---|---|---|
| Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC) Plitidepsin 1.5 mg/day, Placebo, Placebo and Plitidepsin 1.5mg/day - Post COVID-19 Condition, Long COVID Syndrome | Phase 2 | Completed | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | 90 | 2025-02-07 | 2026-10-08 |
| Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA) Plitidepsin - COVID-19 | Phase 2 | Terminated | PharmaMar | 37 | 2023-04-19 | 2024-12-02 |
| Extension Study in a Cohort of Adult Patients With COVID-19 Infection Plitidepsin 1.5 mg / day, Plitidepsin 2.0 mg / day, Plitidepsin 2.5 mg / day - COVID-19 Infection | Phase 1 / Phase 2 | Completed | PharmaMar | 34 | 2022-01-25 | 2024-12-31 |
| Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection Plitidepsin, Dexamethasone, Remdesivir - COVID-19 Infection | Phase 3 | Terminated | PharmaMar | 205 | 2021-06-04 | 2025-02-21 |
| Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19 Plitidepsin 1.5 mg/day, Plitidepsin 2.0 mg/day, Plitidepsin 2.5 mg/day - COVID-19 | Phase 1 | Completed | PharmaMar | 46 | 2020-05-12 | 2022-08-23 |
| Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide plitidepsin, Bortezomib, Dexamethasone - Multiple Myeloma | Phase 2 | Terminated | PharmaMar | 10 | 2017-05-08 | 2020-12-02 |
| A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma plitidepsin - Lymphoma | Phase 2 | Terminated | PharmaMar | 14 | 2016-10-25 | 2020-10-14 |
| Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma Plitidepsin, Bortezomib, Dexamethasone - Multiple Myeloma | Phase 1 | Completed | PharmaMar | 39 | 2014-06-01 | 2020-10-12 |
| Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial plitidepsin - Adult Patients With Unresectable Locally Advanced or Metastatic, Relapsed/Refractory Dedifferentiated Liposarcoma | Phase 2 | Terminated | Institut Bergonié | 24 | 2012-02-01 | 2021-01-25 |
| Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis APLIDIN (plitidepsin) - Myelofibrosis | Phase 2 | Completed | PharmaMar | 12 | 2010-07-01 | 2020-10-12 |
| Aplidin - Dexamethasone in Relapsed/Refractory Myeloma Plitidepsin, Dexamethasone - Relapsed/Refractory Multiple Myeloma | Phase 3 | Completed | PharmaMar | 255 | 2010-06-01 | 2020-11-10 |
| Study of Plitidepsin in Combination With Sorafenib or Gemcitabine in Patients With Advanced Solid Tumors or Lymphomas Plitidepsin and Sorafenib, Gemcitabine and Plitidepsin - Advanced Solid Tumors, Lymphomas | Phase 1 | Completed | PharmaMar | 45 | 2008-12-01 | 2011-06-07 |
| Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia Plitidepsin plus Cytarabine - Relapsed/Refractory Leukemia | Phase 1 / Phase 2 | Terminated | PharmaMar | 3 | 2007-11-01 | 2018-11-09 |
| A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer Aplidin (plitidepsin) - Prostate Cancer | Phase 2 | Terminated | PharmaMar | 8 | 2005-02-01 | 2020-11-24 |
| A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma Plitidepsin - Multiple Myeloma | Phase 2 | Completed | PharmaMar | 51 | 2005-02-01 | 2009-12-24 |
| Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Aplidin® - Leukemia, Lymphoma | Phase 2 | Completed | PharmaMar | 67 | 2004-12-01 | 2018-04-25 |
COVID-19 (5) · Multiple Myeloma (4) · Lymphoma (3) · Neoplasms (3) · Leukemia (2) · Coronavirus Infections (1) · Liposarcoma (1) · Neoplasm Metastasis (1) · Neoplasms, Plasma Cell (1) · Post-Acute COVID-19 Syndrome (1) · Primary Myelofibrosis (1) · Prostatic Neoplasms (1) · Recurrence (1)
PharmaMar (14) · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (1) · Institut Bergonié (1)
Spain (10) · France (8) · United States (7) · Italy (6) · Greece (3) · Belgium (2) · Czechia (2) · Poland (2) · Portugal (2) · Puerto Rico (2) · United Kingdom (2) · Australia (1) · Austria (1) · Brazil (1) · Bulgaria (1)
Antoine Italiano, MD (1) · Celestia Higano, M.D. (1) · Jean Charles Soria, MD (1) · Maha Hussain, M.D. (1) · Mark N. Stein, MD (1) · Mecide Gharibo, M.D. (1) · Pablo Guisado-Vasco, MD (1) · Paul Richardson, MD (1) · Pedro Landete, MD (1) · Roger Paredes, MD (1)