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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: November 18, 2013
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma Drug: GDC-0853 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853 [ Time Frame: Approximately 1 year ]
  • Safety: Maximum tolerated dose (MTD) of GDC-0853 [ Time Frame: Approximately 1 year ]

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

Enrollment: 24
Study Start Date: December 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-escalation Drug: GDC-0853
Multiple escalating doses


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01991184

United States, California
Stanford, California, United States, 94305-5820
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Ohio
Columbus, Ohio, United States, 43212
United States, Oregon
Eugene, Oregon, United States, 97401-8122
Portland, Oregon, United States, 97239
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Washington
Seattle, Washington, United States, 98109
Australia, Queensland
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01991184     History of Changes
Other Study ID Numbers: GO29089
Study First Received: November 18, 2013
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin processed this record on September 21, 2017