A Phase I, Open Label, Multi-Center, Dose Escalation Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Properties of Orally Administered AT-406 in Patients With Advanced Solid Tumors and Lymphomas
Ascenta Therapeutics, Inc. is conducting a clinical trial of the compound Debio 1143
(AT-406), a small molecule second mitochondria-derived activator of caspase C (Smac)
mimetic. In vivo and in vitro studies have demonstrated that Debio 1143 (AT-406) induces
cell death in several tumor models by inhibiting XIAP (X linked IAP), cIAP-1 (cellular
IAP-1) and cIAP-2 (cellular IAP-2), thus releasing initiator and effector caspases to
promote apoptosis. This protocol is a Phase I, dose-escalation, open-label, multi-center
study conducted in patients with advanced solid tumors and lymphomas to evaluate the safety,
tolerability and pharmacology of Debio 1143 (AT-406) in humans when administered orally.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally Tolerated Dose
The primary endpoint of this study is to characterize the safety, and determine the maximum tolerated dose and schedule of Debio 1143 (AT-406) when administered to patients with advanced cancer. Patients will receive Debio 1143 (AT-406) on days 1-5, and 15-19 of a 28 day cycle, days 1-5 of a 21 day cycle, or days 1-14 of a 21 day cycle. For the purpose of determining the MTD, dose limiting toxicities will be evaluated at any time. For the purpose of dose escalation, dose limiting toxicities will be evaluated through the end of 1 cycle.
1 cycle, or any time during treatment
Yes
Claudio Zanna, MD
Study Director
Debiopharm SA
United States: Food and Drug Administration
Debio 1143-101 (AT-406-CS-001)
NCT01078649
February 2010
August 2013
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Michigan Cancer Center | Ann Arbor, Michigan 48109 |