Spots Global Cancer Trial Database for Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas
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Trial Identification
Brief Title: Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas
Official Title: A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Patients With Relapsed or Refractory Lymphoma
Study ID: NCT03786926
Conditions
Interventions
Study Description
Brief Summary: An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas
Detailed Description: This is a Phase 1, open-label, multicenter study of HMPL-689 administered orally to patients with relapsed or refractory lymphoma. HMPL-689 is a selective and potent small molecule inhibitor targeting the isoform phosphoinositide 3'-kinase delta (PI3Kδ), a key component in the B-cell receptor signaling pathway This study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). Dose Escalation Stage (Stage 1): This stage will end when any of the following criteria is met: * The dose level 1 demonstrates an excessive toxicity, ie, 3 dose limiting toxicities (DLTs) are observed out of the first 3 patients at dose level 1. * The maximum sample size is reached. * The MTD and/or RP2D is confirmed. Dose Expansion Stage (Stage 2): To further characterize the safety and explore the preliminary anti-tumor activity of HMPL-689 at RP2D, patients with B cell lymphoma will be enrolled in the dose expansion stage.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Innovative Clinical Research Institute, Anaheim, California, United States
Pacific Cancer Medical Center, Anaheim, California, United States
Ventura County Hematology-Oncology Specialists, Oxnard, California, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Clinical Research Alliance, Inc, Westbury, New York, United States
Levine Cancer Institute- Atrium Health, Charlotte, North Carolina, United States
Baylor Scott and White Research Institute, Dallas, Texas, United States
Renovatio Clinical, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Medical Oncology Associates, P.S., Spokane, Washington, United States
Helsingin yliopistollinen keskussairaala, Helsinki, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
Hopital Henri Mondor, Créteil Cedex, Val De Marne, France
CHU de Nantes - Hotel Dieu, Nantes, , France
CHU de Bordeaux - Hôpital Haut-Lévêque, Pessac, , France
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS, Bologna, , Italy
Ospedale San Raffaele, Milan, , Italy
KO-MED Centra Kliniczne, Biała Podlaska, , Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
BioResearch Group Sp. Z. o. o., Kraków, , Poland
NASZ LEKARZ Osrodek Badan Klinicznych, Toruń, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego, Wroclaw, , Poland
ICO Badalona - Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Seville, , Spain
Hospital Universitario Virgen Macarena, Seville, , Spain
Contact Details
Name: Vijay Jayaprakash, MD
Affiliation: Hutchison Medipharma Limited
Role: STUDY_DIRECTOR
Name: Nilanjan Ghosh, MD
Affiliation: Atrium Health Levine Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Jonathan B Cohen, MD
Affiliation: Emory Winship Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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