23 completed, 4 withdrawn, 2 active not recruiting, 1 recruiting. 20 Phase 1, 12 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 20 | Completed 14, Withdrawn 3, Recruiting 1, Terminated 1, Unknown 1 |
| Phase 2 | 12 | Completed 10, Active not recruiting 1, Withdrawn 1 |
| Phase 3 | 3 | Completed 2, Active not recruiting 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 |
|---|---|---|---|---|---|---|
| To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL Belinostat Injection, Pralatrexate Injection, CHOP - Peripheral T Cell Lymphoma | Phase 3 | Active not recruiting | Acrotech Biopharma Inc. | 504 | 2023-10-04 | 2026-10-15 |
| Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment Pralatrexate Injection - Advanced Solid Tumors, Hematologic Malignancies | Phase 1 | Recruiting | Acrotech Biopharma Inc. | 24 | 2022-12-28 | 2026-02-11 |
| This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD) Difamilast, Placebo - Atopic Dermatitis | Phase 3 | Completed | Acrotech Biopharma Inc. | 153 | 2022-10-01 | 2024-08-15 |
| A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis Difamilast - Atopic Dermatitis | Phase 3 | Completed | Acrotech Biopharma Inc. | 542 | 2022-09-15 | 2024-08-09 |
| Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL Blinatumomab - B-cell Acute Lymphoblastic Leukemia | Phase 2 | Withdrawn | Dorothy Sipkins, MD, PhD | 2022-01-01 | 2022-03-02 | |
| Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma Binimetinib, Belinostat - Metastatic Uveal Melanoma | Phase 2 | Active not recruiting | H. Lee Moffitt Cancer Center and Research Institute | 7 | 2021-12-15 | 2026-04-06 |
| Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer Talazoparib, Belinostat - Metastatic Breast Cancer, Metastatic Castration-resistant Prostate Cancer | Phase 1 | Completed | University of Michigan Rogel Cancer Center | 26 | 2021-03-04 | 2025-01-23 |
| Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation Belinostat, nivolumab, ipilimumab - Metastatic Adenocarcinoma | Phase 1 | Withdrawn | University of Utah | 2020-10-01 | 2020-10-28 | |
| PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients Vincristine Sulfate Liposome, CHOP, R-CHOP - Hematologic Diseases | Phase 1 | Unknown | Acrotech Biopharma Inc. | 56 | 2020-08-15 | 2020-04-16 |
| Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials Belinostat, Atazanavir - Solid Tumor, Hematological Malignancies | Phase 1 | Completed | Acrotech Biopharma Inc. | 8 | 2019-08-05 | 2023-05-03 |
| Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes Belinostat IV - Solid Tumors, Hematological Malignancies | Phase 1 | Completed | Acrotech Biopharma Inc. | 17 | 2016-04-27 | 2025-10-20 |
| To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment. Belinostat - Relapsed/Refractory Solid Tumors/Hematological Malignancies | Phase 1 | Terminated | Acrotech Biopharma Inc. | 18 | 2016-03-01 | 2019-11-20 |
| A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL) Pralatrexate Injection - Peripheral T-Cell Lymphoma (PTCL) | Phase 1 | Completed | Acrotech Biopharma Inc. | 48 | 2015-11-10 | 2021-07-27 |
| Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies Folotyn and Leucovorin, Folic Acid, Vitamin B12 - Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma | Phase 2 | Completed | Acrotech Biopharma Inc. | 36 | 2014-07-01 | 2019-11-20 |
| Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer Belinostat - Advanced Cancer | Phase 1 | Completed | Acrotech Biopharma Inc. | 6 | 2013-09-01 | 2020-01-03 |
| Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL) Belinostat, CHOP - Peripheral T-cell Lymphoma | Phase 1 | Completed | Acrotech Biopharma Inc. | 23 | 2013-05-01 | 2020-01-03 |
| Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn® Folotyn, Fusilev - Non-Small Cell Lung Cancer | Phase 1 | Withdrawn | Acrotech Biopharma Inc. | 2013-04-01 | 2020-01-23 | |
| Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn Fusilev, Folotyn - Non Hodgkin's Lymphoma | Phase 1 | Withdrawn | Acrotech Biopharma Inc. | 2013-03-01 | 2020-01-23 | |
| Safety & Efficacy Study High Dose Evomela Injection for MA Conditioning in MM Patients With Autologous Transplantation High-Dose Melphalan HCL for Injection (Propylene Glycol-Free), Autologous Transplantation - Multiple Myeloma | Phase 2 | Completed | Acrotech Biopharma Inc. | 61 | 2012-12-01 | 2020-04-21 |
| 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 |
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Lymphoma, T-Cell, Peripheral (7) · Hematologic Neoplasms (6) · Lymphoma (5) · Recurrence (5) · Lymphoma, Non-Hodgkin (4) · Lymphoma, T-Cell (3) · Adenocarcinoma (2) · Breast Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (2) · Dermatitis, Atopic (2) · Leukemia (2) · Lymphoma, T-Cell, Cutaneous (2) · Multiple Myeloma (2) · Mycosis Fungoides (2) · Neoplasm Metastasis (2)
10-propargyl-10-deazaaminopterin (12) · belinostat (10) · Vincristine (8) · Folic Acid (6) · Vitamin B 12 (6) · Doxorubicin (3) · Prednisone (3) · Cyclophosphamide (2) · Injections (2) · Levoleucovorin (2) · Melphalan (2) · Rituximab (2) · difamilast (2) · AC protocol (1) · Atazanavir Sulfate (1)
United States (27) · France (3) · Italy (3) · Spain (3) · Belgium (2) · Canada (2) · Hungary (2) · United Kingdom (2) · Argentina (1) · Croatia (1) · Czechia (1) · Germany (1) · Poland (1) · South Korea (1) · Taiwan (1)
Wasim Khan, MD (4) · Erard Gilles, MD (2) · Michael Saunders, MD (2) · Agop Bedikian, MD (1) · Ahmad Tarhini, MD, PhD (1) · Ahmed Sawas, MD (1) · Allen Wayne (1) · Brian Matthews, MD (1) · Deborah Thomas, MD (1) · Dorothy Sipkins, MD (1) · Erard Gilles, MD, MSc (1) · Francine Foss, MD (1) · Gareth Morgan, Prof. (1) · Garry Weems, Pharm.D. (1) · Garry Weems, PharmD (1)
PMID 33602316, PMID 38029357, PMID 40546726
2008 (1)