Spots Global Cancer Trial Database for A Study of HMPL-689 in Patients With Lymphomas Failed of Standard of Care or no Standard of Care Existed

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Trial Identification

Brief Title: A Study of HMPL-689 in Patients With Lymphomas Failed of Standard of Care or no Standard of Care Existed

Official Title: A Phase 1 Open-Label Study to Assess the Safety, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Patients With Lymphomas Failed of Standard of Care or No Standard of Care Existed

Study ID: NCT03128164

Conditions

Lymphomas

Interventions

HMPL-689

Study Description

Brief Summary: This is a Phase 1, open-label study of HMPL-689 administered orally to patients with lymphoma for whom failed of standard care or have no standard of care.This study consists of a dose escalation stage (Stage I) and a dose expansion stage (Stage II).

Detailed Description: Both Stage I and Stage II include the following periods: screening period, treatment period, safety follow-up period, and extended progression free survival (PFS) follow-up period, as defined in Dose Escalation Stage (Stage I). Dose escalation will be performed according to a modified toxicity probability interval scheme-2 (mTPI-2).To further characterize safety and efficacy of HMPL-689 at RP2D, expansion stage of the study enrolled 144 patients with B cell lymphoma, including CLL/ SLL, FL, MZL, DLBCL, MCL and PTCL. Patients were treated with RP2D as starting dose.