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

NCT01991184 | Completed Phase 1

• 1 other identifier: GO29089
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Dose-escalation

EXPERIMENTAL

Drug: GDC-0853

Interventions

GDC-0853 DRUG

Multiple escalating doses

Also known as: Fenebrutinib

Dose-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (10)

Stanford Cancer Center

Stanford, California, 94305-5820, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43212, United States

Location

Willamette Valley Cancer Ctr - 520 Country Club

Eugene, Oregon, 97401-8122, United States

Location

Oregon Health Sciences Uni

Portland, Oregon, 97239, United States

Location

Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

Nashville, Tennessee, 37203, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

Woolloongabba, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre; Department of Haematology

Melbourne, Victoria, 3002, Australia

Location

Linear Clinical Research Limited

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Leukemia, Lymphoid; Bronchiolitis Obliterans Syndrome; Lymphoma, Large B-Cell, Diffuse

Interventions

fenebrutinib

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: December 16, 2013
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

US (7); AU (3)