Phase I-II Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
Anus | Breast - Female | Breast - Male | Colon | Esophagus | Hodgkin's Lymphoma | Kidney | Larynx | Lip, Oral Cavity and Pharynx | Liver | Lung | Melanoma, skin | Non-Hodgkin's Lymphoma | Other Digestive Organ | Other Endocrine System | Other Female Genital | Other Male Genital | Other Respiratory and Intrathoracic Organs | Other Skin | Other Urinary | Ovary | Pancreas | Prostate | Rectum | Small Intestine | Soft Tissue | Stomach | Thyroid | Phase I | Unknown Sites | Urinary Bladder
What is the purpose of this trial?
Phase 1: To assess safety, and to identify the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and the recommended dosing regimen of ASTX660.
Phase 2: To assess preliminary efficacy, as determined by response rate in certain tumor types.
- To determine the pharmacokinetic (PK) parameters of orally administered ASTX660 in humans.
- To evaluate other efficacy parameters, such as duration of response and progression-free survival.
- To evaluate relevant pharmacodynamic (PD) targets and potential biomarkers of ASTX660 activity.
- Ages18 years and older
- Trial withAstex Pharmaceuticals, Inc.
- Start Date04/14/2016
- End Date06/30/2019
- Last Updated10/09/2018
- Study HIC#1505015798