Back to resultsA Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
Primary Purpose
Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GDC-0853
Sponsored by
About this trial
This is an interventional treatment trial for Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
Eligibility 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
Sites / Locations
- Stanford Cancer Center
- Washington University School of Medicine
- The Ohio State University Wexner Medical Center
- Willamette Valley Cancer Ctr - 520 Country Club
- Oregon Health Sciences Uni
- Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
- Seattle Cancer Care Alliance
- Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
- Peter MacCallum Cancer Centre; Department of Haematology
- Linear Clinical Research Limited
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose-escalation
Arm Description
Outcomes
Primary Outcome Measures
Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
Safety: Maximum tolerated dose (MTD) of GDC-0853
Secondary Outcome Measures
Safety: Incidence of adverse events
Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853
Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853
Objective response to GDC-0853
Progression-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01991184
Brief Title
A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2013 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose-escalation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GDC-0853
Other Intervention Name(s)
Fenebrutinib
Intervention Description
Multiple escalating doses
Primary Outcome Measure Information:
Title
Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
Time Frame
Approximately 1 year
Title
Safety: Maximum tolerated dose (MTD) of GDC-0853
Time Frame
Approximately 1 year
Secondary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
Approximately 2 years
Title
Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853
Time Frame
35 days
Title
Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853
Time Frame
35 days
Title
Objective response to GDC-0853
Time Frame
Approximately 2 years
Title
Progression-free survival
Time Frame
Approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5820
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Willamette Valley Cancer Ctr - 520 Country Club
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-8122
Country
United States
Facility Name
Oregon Health Sciences Uni
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Peter MacCallum Cancer Centre; Department of Haematology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Linear Clinical Research Limited
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
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