Clinical trial NCT01991184: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
timeFrame: Approximately 1 year
measure: Safety: Maximum tolerated dose (MTD) of GDC-0853
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: Approximately 2 years
measure: Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853
timeFrame: 35 days
measure: Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853
timeFrame: 35 days
measure: Objective response to GDC-0853
timeFrame: Approximately 2 years
measure: Progression-free survival
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Ctr - 520 Country Club
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences Uni
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
state: Tennessee
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre; Department of Haematology
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research Limited
state: Western Australia
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: