Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

Lymphoma Clinical Trial

Official title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

ASTX660 is a synthetic small molecule dual antagonist of cellular inhibitor of apoptosis protein (cIAP) 1 and X-linked inhibitor of apoptosis protein (XIAP) that has been shown to have potent proapoptotic and tumor growth inhibitory activity in nonclinical models. The Phase 1 portion of the study (completed) will determine the MTD, RP2D, and recommended dosing regimen. The Phase 2 portion will evaluate activity in selected tumor types. Subjects will continue to receive their assigned treatment throughout the study until the occurrence of disease progression, death, or unacceptable treatment-related toxicity, or until the study is closed by the sponsor. ;

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumors

• NCT number: NCT02503423
• Study type: Interventional
• Source: Astex Pharmaceuticals, Inc.
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2015
• Completion date: October 2024