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

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ClinicalTrials.gov Identifier: NCT01991184
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 16, 2013
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose-escalation Drug: GDC-0853
Multiple escalating doses


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

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

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

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991184


Locations
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United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5820
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
United States, Oregon
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, United States, 97401-8122
Oregon Health Sciences Uni
Portland, Oregon, United States, 97239
United States, Tennessee
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, Queensland
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01991184     History of Changes
Other Study ID Numbers: GO29089
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin