CLINICAL TRIALS PROFILE FOR ASTX660
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Clinical Trials for ASTX660
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02503423 ↗ | Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas | Recruiting | Astex Pharmaceuticals | Phase 1/Phase 2 | This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available. |
| NCT02503423 ↗ | Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas | Recruiting | Astex Pharmaceuticals, Inc. | Phase 1/Phase 2 | This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available. |
| NCT04155580 ↗ | A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) | Recruiting | Astex Pharmaceuticals, Inc. | Phase 1 | To evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months. |
| NCT04362007 ↗ | A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma | Recruiting | Otsuka Pharmaceutical Co., Ltd. | Phase 1/Phase 2 | Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2. Phase 1 (ATLL expansion part): Evaluate the safety of ASTX660 at RD in patients with r/r ATLL. Phase 2 : Evaluate the efficacy of ASTX660 at RD in patients with r/r PTCL. |
| NCT04411030 ↗ | A Study to Investigate the Effect of CYP3A4 Inhibition on the Single Dose Pharmacokinetics of ASTX660 and the Effect of a Single Dose of ASTX660 on the Pharmacokinetics of the CYP3A4 Substrate Midazolam | Completed | Astex Pharmaceuticals, Inc. | Phase 1 | In Part 1, the primary objective is to investigate the effect of multiple doses of itraconazole, an inhibitor of CYP3A4, on the pharmacokinetic (PK) profile of a single dose of ASTX660. In Part 2, the primary objective is to investigate the effect of a single dose of ASTX660 on the pharmacokinetics of the CYP3A4 substrate midazolam and its metabolite, 1-hydroxy midazolam. Safety and tolerability of a single dose of ASTX660 in the absence and presence of multiple doses of the CYP3A4 inhibitor itraconazole and in the presence of a single dose of the CYP3A4 substrate midazolam will also be evaluated. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for ASTX660
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Clinical Trial Sponsors for ASTX660
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