ATHENEX, INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2022-10-01: Study NCT05487651; Company role Lead sponsor; Phase Phase 1; Status Unknown.
- 2021-08-11: Study NCT04878484; Company role Lead sponsor; Phase Phase 1; Status Withdrawn.
- 2021-04-21: Study NCT04136834; Company role Lead sponsor; Phase Phase 1; Status Unknown.
- 2019-08-05: Study NCT03892018; Company role Lead sponsor; Phase Phase 1; Status Terminated.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2022-10-01 | NCT05487651 Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies | Lead sponsor | Phase 1 | Unknown | NHL, Relapsed, Adult; B-cell Lymphoma; B-cell Leukemia; DLBCL - Diffuse Large B Cell Lymphoma; ALL, Adult B Cell; ALL, Childhood; CLL/SLL | 36 | 2024-12 |
| 2021-08-11 | NCT04878484 Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors | Lead sponsor | Phase 1 | Withdrawn | Advanced Solid Tumor | 0 | 2024-12 |
| 2021-04-21 | NCT04136834 A Phase I Open-label Study for Subjects With Advanced Malignancies | Lead sponsor | Phase 1 | Unknown | Advanced Solid Malignancies | 62 | 2022-12-01 |
| 2019-08-05 | NCT03892018 The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol | Lead sponsor | Phase 1 | Terminated | Solid Tumor, Adult | 29 | 2023-05-12 |
| 2019-04-22 | NCT04993040 A PK Study of Oraxol in Breast Cancer Patients | Lead sponsor | Phase 1 | Completed | Breastcancer | 24 | 2020-12-09 |
| 2018-12-21 | NCT03544567 A Study of Oraxol in Subjects With Cutaneous Angiosarcoma | Lead sponsor | Phase 2 | Completed | Angiosarcoma of Skin | 48 | 2023-05-12 |
| 2018-10-25 | NCT03588039 Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors | Lead sponsor | Phase 1 | Terminated | Solid Tumor | 34 | 2023-05-12 |
| 2018-09-07 | NCT03575780 Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis | Lead sponsor | Phase 1 | Completed | Actinic Keratoses | 18 | 2019-10-10 |
| 2018-07-19 | NCT03987685 Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies | Lead sponsor | Phase 1 | Completed | Solid Tumor | 10 | 2021-01-09 |
| 2017-10-25 | NCT04168957 An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007 | Lead sponsor | Phase 1 | Terminated | Breastcancer | 11 | 2020-11-12 |
| 2017-09-18 | NCT03285477 A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp | Collaborator Lead: Almirall, S.A. | Phase 3 | Completed Results posted | Actinic Keratoses | 351 | 2019-04-24 |
| 2017-09-15 | NCT03285490 A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) | Collaborator Lead: Almirall, S.A. | Phase 3 | Completed Results posted | Actinic Keratosis | 351 | 2019-04-24 |
| 2017-04-20 | NCT02963168 A DRF Study to Evaluate Safety, Tolerability, PK, and Activity of Oradoxel Monotherapy in Subjects w Adv. Malignancies | Lead sponsor | Phase 1 | Unknown | Solid Tumor | 24 | 2020-04-30 |
| 2016-12-08 | NCT02970539 Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers | Lead sponsor | Phase 1 | Unknown | Gastric Cancer; Esophageal Cancer; Gastro-esophageal Cancer | 36 | 2022-12-31 |
| 2016-04-11 | NCT02838628 Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp | Collaborator Lead: Almirall, S.A. | Phase 2 | Completed Results posted | Actinic Keratosis | 168 | 2017-12-22 |
| 2016-03 | NCT02730481 A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies | Lead sponsor | Phase 1 | Completed | Solid Tumor | 38 | 2021-05 |
| 2015-12-02 | NCT02594371 Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer | Lead sponsor | Phase 3 | Completed | Metastatic Breast Cancer | 402 | 2022-06-30 |
| 2015-09-23 | NCT04180384 A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients | Lead sponsor | Phase 2 | Completed | Solid Tumor | 44 | 2021-06-15 |
| 2015-08-01 | NCT04035473 A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel | Lead sponsor | Phase 1 | Completed Results posted | Solid Tumor | 42 | 2019-03-27 |
| 2014-12 | NCT02337205 Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis | Lead sponsor | Phase 1 | Completed | Actinic Keratosis | 29 | 2016-03 |
| 2014-12 | NCT02326441 Safety, Tolerability & PK of KX2-361 in Subjects w Adv. Malignancies Refractory to Conventional Therapies | Lead sponsor | Phase 1 | Completed | Advance Malignancies | 29 | 2018-05-23 |
| 2014-09-05 | NCT02250157 A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies | Lead sponsor | Phase 1 | Completed | Solid Tumor | 35 | 2020-03-04 |
| 2013-12 | NCT01397799 Evaluation of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia (AML) | Lead sponsor | Phase 1 | Completed | Acute Myelogenous Leukemia | 24 | 2014-07 |
| 2013-10 | NCT01967043 A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies | Lead sponsor | Phase 1 | Completed | Solid Tumor | 34 | 2016-09 |
| 2010-02 | NCT01074138 Safety and Efficacy Study of KX2-391 for Treatment of Bone-Metastatic, Castration-Resistant Prostate Cancer | Lead sponsor | Phase 2 | Completed | Bone-Metastatic, Castration-Resistant Prostate Cancer | 31 | 2012-10 |
| 2007-11 | NCT00658970 Evaluation of KX2-391 in Patients With Advanced Malignancies | Lead sponsor | Phase 1 | Completed | Solid Tumors; Lymphoma | 50 | 2011-05 |