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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGDC-0853

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 21, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Genentech, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Genentech, Inc.
Interventions being studied: Drug: GDC-0853

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Recurrent or relapsed→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Stanford Cancer CenterStanford, California
Washington University School of MedicineSt Louis, Missouri
The Ohio State University Wexner Medical CenterColumbus, Ohio
Willamette Valley Cancer Ctr - 520 Country ClubEugene, Oregon
Oregon Health Sciences UniPortland, Oregon
Sarah Cannon Cancer Center - Tennessee Oncology, PllcNashville, Tennessee
Seattle Cancer Care AllianceSeattle, Washington
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical OncologyWoolloongabba, Queensland
Peter MacCallum Cancer Centre; Department of HaematologyMelbourne, Victoria
Linear Clinical Research LimitedNedlands, Western Australia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 21, 2022. Always confirm current availability with the study team.

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