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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01991184

Collaborator

(none)

Enrollment

Locations

Arm

98.7

Actual Duration (Months)

2.4

Patients Per Site

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

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 :

Dec 16, 2013

Actual Primary Completion Date :

Mar 8, 2022

Actual Study Completion Date :

Mar 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose-escalation	Drug: GDC-0853 Multiple escalating doses Other Names: Fenebrutinib

Arm

Intervention/Treatment

Experimental: Dose-escalation

Drug: GDC-0853

Multiple escalating doses

Other Names:

Fenebrutinib

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford Cancer Center	Stanford	California	United States	94305-5820
2	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
3	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43212
4	Willamette Valley Cancer Ctr - 520 Country Club	Eugene	Oregon	United States	97401-8122
5	Oregon Health Sciences Uni	Portland	Oregon	United States	97239
6	Sarah Cannon Cancer Center - Tennessee Oncology, Pllc	Nashville	Tennessee	United States	37203
7	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
8	Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology	Woolloongabba	Queensland	Australia	4102
9	Peter MacCallum Cancer Centre; Department of Haematology	Melbourne	Victoria	Australia	3002
10	Linear Clinical Research Limited	Nedlands	Western Australia	Australia	6009