CLINICAL TRIALS PROFILE FOR ASTX660

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.
NCT04479800 ↗	Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers	Completed	Astex Pharmaceuticals, Inc.	Phase 1	This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover study in which healthy adult participants will receive three separate single-dose administrations of ASTX660 capsules under three different conditions.

Clinical Trial Conditions for ASTX660

Condition Name

Condition Name
Intervention	Trials
Healthy Volunteer	2
Locally Advanced HER2-Negative Breast Carcinoma	1
Recurrent Primary Peritoneal Clear Cell Adenocarcinoma	1
Metastatic Triple-Negative Breast Carcinoma	1

Condition MeSH

Condition MeSH
Intervention	Trials
Lymphoma	3
Lymphoma, T-Cell, Peripheral	2
Lymphoma, T-Cell	2
Triple Negative Breast Neoplasms	2

Clinical Trial Locations for ASTX660

Trials by Country

Trials by Country
Location	Trials
United States	38
Canada	6
United Kingdom	5
France	5
Spain	3

Trials by US State

Trials by US State
Location	Trials
Georgia	3
Texas	3
Illinois	2
Connecticut	2
California	2

Clinical Trial Progress for ASTX660

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
PHASE1	3
Phase 1/Phase 2	3
Phase 1	4

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
RECRUITING	4
Not yet recruiting	3
Completed	2

Clinical Trial Sponsors for ASTX660

Sponsor Name

Sponsor Name
Sponsor	Trials
Astex Pharmaceuticals, Inc.	7
National Cancer Institute (NCI)	2
Astex Pharmaceuticals	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	10
Other	4
NIH	2