23 completed, 5 terminated, 1 withdrawn. 19 Phase 2, 16 Phase 1, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 14, Terminated 4, Withdrawn 1 |
| Phase 1 | 16 | Completed 12, Terminated 3, Withdrawn 1 |
| Phase 3 | 5 | Completed 5 |
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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 |
|---|---|---|---|---|---|---|
| A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors VIO-01 - Advanced or Metastatic Solid Tumors, Breast Cancer | Phase 1 / Phase 2 | Terminated | Valerio Therapeutics | 6 | 2024-01-10 | 2025-03-17 |
| Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors AsiDNA, Olaparib - Metastatic Castration-resistant Prostate Cancer, Recurrent Epithelial Ovarian Cancer | Phase 1 / Phase 2 | Completed | Valerio Therapeutics | 3 | 2023-02-20 | 2024-09-19 |
| AsiDNA (a DNA Repair Inhibitor) Administered IntraVenously in Advanced Solid Tumors AsiDNA - Advanced Cancer | Phase 1 | Completed | Valerio Therapeutics | 33 | 2018-04-05 | 2022-03-24 |
| Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers Clonidine MBT 50µg, Clonidine MBT 100µg, Catapres 100μg - Healthy | Phase 1 | Completed | Valerio Therapeutics | 36 | 2015-09-01 | 2016-04-18 |
| Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma Doxorubicin 20 mg/m2, Doxorubicin 30 mg/m2, Best Standard of Care - Carcinoma, Hepatocellular | Phase 3 | Completed | Valerio Therapeutics | 397 | 2012-06-01 | 2021-06-02 |
| Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma naked DNA coding for protein AMEP - Melanoma | Phase 1 / Phase 2 | Withdrawn | Valerio Therapeutics | 2012-06-01 | 2015-09-11 | |
| MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC Belinostat, Carboplatin, Paclitaxel - Stage IV Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Completed | Acrotech Biopharma Inc. | 23 | 2010-12-01 | 2020-01-06 |
| A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies Belinostat, Warfarin - Solid Tumor, Hematological Malignancy | Phase 1 | Completed | Spectrum Pharmaceuticals, Inc | 27 | 2010-12-01 | 2015-09-23 |
| A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer Belinostat and Erlotinib - Non Small Cell Lung Cancer | Phase 1 / Phase 2 | Terminated | Herlev Hospital | 5 | 2010-10-01 | 2020-10-19 |
| Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma naked DNA coding for protein AMEP - Melanoma | Phase 1 | Terminated | Valerio Therapeutics | 5 | 2010-07-01 | 2015-09-11 |
| Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis Clonidine Lauriad® 50µg, Clonidine Lauriad® 100µg, Placebo Lauriad® - Oral Mucositis | Phase 2 | Completed | Valerio Therapeutics | 183 | 2010-04-01 | 2017-11-28 |
| Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary belinostat, carboplatin, paclitaxel, carboplatin, paclitaxel - Carcinoma of Unknown Primary | Phase 2 | Completed | Valerio Therapeutics | 89 | 2009-02-01 | 2015-07-28 |
| Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma Belinostat - Peripheral T-cell Lymphoma | Phase 2 | Completed | Spectrum Pharmaceuticals, Inc | 129 | 2008-12-15 | 2021-10-29 |
| Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy PXD101, idarubicin - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Completed | Valerio Therapeutics | 41 | 2007-08-01 | 2015-07-28 |
| Phase 3 Clinical Study for the Treatment of Cold Sore Acyclovir Lauriad, Placebo - Herpes Labialis | Phase 3 | Completed | Valerio Therapeutics | 1727 | 2007-05-01 | 2012-12-21 |
| A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma PXD101 - Multiple Myeloma | Phase 2 | Terminated | Valerio Therapeutics | 4 | 2007-03-01 | 2015-07-08 |
| A Phase I/II Study to Assess the Safety and Tolerability of APO866 for the Treatment of Refractory B-CLL APO866 - B-cell Chronic Lymphocytic Leukemia | Phase 1 / Phase 2 | Completed | Valerio Therapeutics | 10 | 2007-02-01 | 2015-09-23 |
| A Phase I Dose Finding Study of APO010 in Patients With Solid Tumors APO010 - Cancer | Phase 1 | Completed | Valerio Therapeutics | 26 | 2007-02-01 | 2015-09-17 |
| A Study of APO866 for the Treatment of Cutaneous T-cell Lymphoma APO866 - Cutaneous T-cell Lymphoma | Phase 2 | Completed | Valerio Therapeutics | 25 | 2007-02-01 | 2015-07-08 |
| A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas PXD101, Doxorubicin - Dose Escalation: Solid Tumors, MTD: Soft Tissue Sarcomas | Phase 1 / Phase 2 | Completed | Valerio Therapeutics | 41 | 2006-12-01 | 2015-07-28 |
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Breast Neoplasms (4) · Carcinoma, Non-Small-Cell Lung (4) · Ovarian Neoplasms (4) · Lung Neoplasms (3) · Melanoma (3) · Neoplasms (3) · Sarcoma (3) · Urinary Bladder Neoplasms (3) · Adenosarcoma (2) · Carcinoma, Ovarian Epithelial (2) · Carcinoma, Small Cell (2) · Chondrosarcoma (2) · Colorectal Neoplasms (2) · Esophageal Neoplasms (2) · Fibrosarcoma (2)
belinostat (13) · Carboplatin (3) · N-(4-(1-benzoylpiperidin-4-yl)butyl)-3-(pyridin-3-yl)acrylamide (3) · Paclitaxel (3) · Dexrazoxane (2) · Doxorubicin (2) · Electroporation (2) · CP protocol (1) · Clonidine (1) · Clotrimazole (1) · Dexamethasone (1) · Erlotinib Hydrochloride (1) · Fluorouracil (1) · Idarubicin (1) · Mega-Fas-ligand (1)
United States (16) · France (12) · Denmark (10) · Germany (10) · United Kingdom (9) · Switzerland (4) · Austria (3) · Belgium (3) · Hungary (3) · Italy (3) · Poland (3) · Spain (3) · Canada (2) · Israel (2) · Netherlands (2)
Henning T Mouridsen, MD, Dr. med. (2) · Adam Lerner, MD (1) · Alexander Philipovskiy, M.D., PhD (1) · Amanda Cashen, MD (1) · Andreas Neubauer, MD (1) · Andreas Viardot, MD (1) · Andrei Shustov, MD (1) · Beata Holkova, MD (1) · Bernard Poiesz, MD (1)
PMID 17185744, PMID 25404094, PMID 26921086, PMID 28726169, PMID 30954567, PMID 32839491
2008 (1), 2009 (1)