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Brief Title: A Study of FCN-338 in Patients With Chronic CLL/SLL
Official Title: A Phase I Trial to Evaluate the Tolerability、Pharmacokinetics and Preliminary Antitumor Activity of FCN-338 in Patients With CLL/SLL
Study ID: NCT04682808
Brief Summary: This study is being done to evaluate the Tolerability、Pharmacokinetics and Preliminary antitumor activity of oral FCN-338 for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have failed or are intolerant to one or more lines of established therapy or for whom no other treatment options are available.
Detailed Description: This is a multicenter, open-label, Phase I dose escalation study of Tolerability、Pharmacokinetics and Preliminary antitumor activity of FCN-338 in ascending cohorts to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL patients. This is to be followed by a cohort expansion phase at the MTD or recommended oral dose.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
SUN YAT-University Cancer Center, GuangZhou, Guang Dong, China
Name: Huang Hui Qiang, MD
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR