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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01991184
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : March 23, 2020
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE December 16, 2013
Estimated Primary Completion Date February 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
Intervention  ICMJE Drug: GDC-0853
Multiple escalating doses
Other Name: Fenebrutinib
Study Arms  ICMJE Experimental: Dose-escalation
Intervention: Drug: GDC-0853
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 26, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
Estimated Study Completion Date  ICMJE February 27, 2021
Estimated Primary Completion Date February 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01991184
Other Study ID Numbers  ICMJE GO29089
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP