Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors

Summary

Study STML-901-0119 was a dose-escalation study evaluating multiple doses and schedules of orally administered SL-901 in patients with advanced solid tumors.

Timeline

Start

2021-03-19

Primary completion

2023-05-05

Completion

2023-05-05

Outcome

Outcome not reported

Stopped: “The study was stopped after careful consideration of the landscape of similar drugs and evolving standard of care.”

Publications

• Background Ahn C. An evaluation of phase I cancer clinical trial designs. Stat Med. 1998 Jul 30;17(14):1537-49. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-f.
• Background Courtney KD, Corcoran RB, Engelman JA. The PI3K pathway as drug target in human cancer. J Clin Oncol. 2010 Feb 20;28(6):1075-83. doi: 10.1200/JCO.2009.25.3641. Epub 2010 Jan 19.
• Background Gatsonis C, Greenhouse JB. Bayesian methods for phase I clinical trials. Stat Med. 1992 Jul;11(10):1377-89. doi: 10.1002/sim.4780111011.
• Background Greenwell IB, Ip A, Cohen JB. PI3K Inhibitors: Understanding Toxicity Mechanisms and Management. Oncology (Williston Park). 2017 Nov 15;31(11):821-8.
• Background Krause G, Hassenruck F, Hallek M. Copanlisib for treatment of B-cell malignancies: the development of a PI3K inhibitor with considerable differences to idelalisib. Drug Des Devel Ther. 2018 Aug 21;12:2577-2590. doi: 10.2147/DDDT.S142406. eCollection 2018.
• Background Liu P, Cheng H, Roberts TM, Zhao JJ. Targeting the phosphoinositide 3-kinase pathway in cancer. Nat Rev Drug Discov. 2009 Aug;8(8):627-44. doi: 10.1038/nrd2926.
• Background Storer BE. Design and analysis of phase I clinical trials. Biometrics. 1989 Sep;45(3):925-37.

Drugs

Indications