A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.

Completed · Phase 1

Conditions studied: Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT01991184

Run by

Genentech, Inc.

People needed

24

Starts

2013-12-16

Expected to finish

2022-03-08

Last updated by the study team

2022-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/= 18 years
• ECOG score of 0-1
• One of the following histologically-documented hematologic malignancies for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
• At least one site of disease that, as seen on CT scan, is > 1.5 cm in the greatest transverse diameter or > 1.0 cm in short axis diameter (except for patients with CLL)
• An available tumor specimen
• Adequate hematologic and organ function
• For female patients of childbearing potential and male patients with partners of childbearing potential, use of effective contraceptive(s) as defined by protocol for the duration of the study

You may not qualify if…

• Life expectancy < 12 weeks
• < 3 weeks since the last anti-tumor therapy, including chemotherapy, biologic, experimental, hormonal or radiotherapy (with the exception of leuprolide or similar medications for prostate cancer)
• Recent major surgical procedure or traumatic injury, or unhealed incisions or wounds
• Active infection requiring IV antibiotics
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
• Primary CNS malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
• History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, Stage I uterine cancer, or other cancers with a similar outcome
• Cardiovascular dysfunction, including ventricular dysrhythmias or risk factors for ventricular dysrhythmias
• Pregnancy, or lactation
• Any other diseases that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.