CLINICAL TRIALS PROFILE FOR ENSARTINIB HYDROCHLORIDE
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All Clinical Trials for ensartinib hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01625234 ↗ | Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer | Completed | Xcovery Holding Company, LLC | Phase 1/Phase 2 | 2012-06-01 | This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the efficacy of X-396. |
| NCT02767804 ↗ | eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients | Active, not recruiting | Xcovery Holding Company, LLC | Phase 3 | 2016-06-01 | The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor. |
| NCT02898116 ↗ | Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer | Completed | Cancer Research Institute, New York City | Phase 1/Phase 2 | 2017-05-10 | This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination. |
| NCT02898116 ↗ | Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer | Completed | MedImmune LLC | Phase 1/Phase 2 | 2017-05-10 | This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination. |
| NCT02898116 ↗ | Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer | Completed | Xcovery Holding Company, LLC | Phase 1/Phase 2 | 2017-05-10 | This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination. |
| NCT02898116 ↗ | Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer | Completed | Ludwig Institute for Cancer Research | Phase 1/Phase 2 | 2017-05-10 | This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination. |
| NCT02959619 ↗ | Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK | Unknown status | Betta Pharmaceuticals Co., Ltd. | Phase 1 | 2017-03-06 | This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ensartinib hydrochloride
Condition Name
| Condition Name for ensartinib hydrochloride | |
| Intervention | Trials |
| Non-small Cell Lung Cancer | 10 |
| Non Small Cell Lung Cancer | 3 |
| Recurrent Malignant Solid Neoplasm | 2 |
| Refractory Central Nervous System Neoplasm | 2 |
| [disabled in preview] | 1 |
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Clinical Trial Locations for ensartinib hydrochloride
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Clinical Trial Progress for ensartinib hydrochloride
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Clinical Trial Sponsors for ensartinib hydrochloride
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