This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed in subsets of patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Multiple escalating doses
Stanford Cancer Center
Stanford, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
Time frame: Approximately 1 year
Safety: Maximum tolerated dose (MTD) of GDC-0853
Time frame: Approximately 1 year
Safety: Incidence of adverse events
Time frame: Approximately 2 years
Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853
Time frame: 35 days
Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853
Time frame: 35 days
Objective response to GDC-0853
Time frame: Approximately 2 years
Progression-free survival
Time frame: Approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, United States
Oregon Health Sciences Uni
Portland, Oregon, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne, Victoria, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia