6 completed, 2 terminated. 3 Phase 1, 3 Phase 3, 1 Not applicable, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 3 | Terminated 2, Completed 1 |
| Not applicable | 1 | Completed 1 |
| Phase 2 | 1 | Completed 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 |
|---|---|---|---|---|---|---|
| Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron), SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron) - Healthy Volunteers | Phase 1 | Completed | Solasia Pharma K.K. | 66 | 2021-10-13 | 2022-02-09 |
| Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer Calmangafodipir (5 µmol/kg), Placebo - Colorectal Cancer, Chemotherapy-induced Peripheral Neuropathy | Phase 3 | Terminated | Egetis Therapeutics AB (publ) | 301 | 2019-01-07 | 2022-01-26 |
| Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M) Calmangafodipir (2 µmol/kg), Calmangafodipir (5 µmol/kg), Placebo - Colorectal Cancer, Chemotherapy-induced Peripheral Neuropathy | Phase 3 | Terminated | Egetis Therapeutics AB (publ) | 291 | 2018-11-07 | 2021-12-17 |
| A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis episil®, Kang Su - Chemotherapy- and/or Radiation-induced Oral Mucositis | Not applicable | Completed | Solasia Pharma K.K. | 60 | 2017-12-26 | 2018-06-08 |
| A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) SP-02L (darinaparsin for injection) - Peripheral T-Cell Lymphoma | Phase 2 | Completed | Solasia Pharma K.K. | 67 | 2016-03-25 | 2024-01-26 |
| A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting SP-01 (Granisetron Transdermal Delivery System), Granisetron Hydrochloride Tablet - Chemotherapy-induced Nausea and Vomiting | Phase 3 | Completed | Solasia Pharma K.K. | 313 | 2013-08-01 | 2023-04-12 |
| A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea SP-02L (darinaparsin for injection) - Peripheral T-cell Lymphoma | Phase 1 | Completed | Solasia Pharma K.K. | 6 | 2012-09-01 | 2014-09-04 |
| A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) SP-02L (darinaparsin for injection) - Peripheral T-cell Lymphoma | Phase 1 | Completed | Solasia Pharma K.K. | 17 | 2011-09-01 | 2015-08-13 |
Lymphoma, T-Cell, Peripheral (3) · Colorectal Neoplasms (2) · Neoplasms (2) · Neoplasm Metastasis (1) · Peripheral Nervous System Diseases (1) · Vomiting (1)
Injections (3) · darinaparsin (3) · N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid (2) · Granisetron (1)
Japan (4) · South Korea (4) · Hong Kong (3) · Taiwan (3) · Belgium (2) · China (2) · Czechia (2) · France (2) · Germany (2) · Italy (2) · Spain (2) · United Kingdom (2) · Hungary (1) · United States (1)
Stefan Carlsson, MD (2) · Bernard Man Yung Cheung (1) · Guoyao Tang (1) · Shukui Qin, MD (1) · Xinchen Sun (1)
PMID 33051668, PMID 36308441, PMID 36661315
2017 (1)