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

An Open-Label, Phase I, Dose-Escalation Study Evaluating The Safety And Tolerability Of Gdc-0853 In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia

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 Overview

• Status: Completed
• Conditions: Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Drug: GDC-0853

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Peter MacCallum Cancer Centre; Department of Haematology
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research Limited
• United States
  • California
    • Stanford, California, United States, 94305-5820
      • Stanford Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Ohio
    • Columbus, Ohio, United States, 43212
      • The Ohio State University Wexner Medical Center
  • Oregon
    • Eugene, Oregon, United States, 97401-8122
      • Willamette Valley Cancer Ctr - 520 Country Club
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences Uni
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose-escalation	Drug: GDC-0853; Multiple escalating doses; Other Names: Fenebrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853	Approximately 1 year
Safety: Maximum tolerated dose (MTD) of GDC-0853	Approximately 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	Approximately 2 years
Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853	35 days
Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853	35 days
Objective response to GDC-0853	Approximately 2 years
Progression-free survival	Approximately 2 years

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2013
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: GO29089