Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT01991184

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 10 Locations for this study

See Locations Near You

Stanford Cancer Center
Stanford California, 94305, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43212, United States
Willamette Valley Cancer Ctr - 520 Country Club
Eugene Oregon, 97401, United States
Oregon Health Sciences Uni
Portland Oregon, 97239, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville Tennessee, 37203, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba Queensland, 4102, Australia
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne Victoria, 3002, Australia
Linear Clinical Research Limited
Nedlands Western Australia, 6009, Australia

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT01991184

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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