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

Genentech

Status and phase

Completed

Phase 1

Conditions

Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma

Treatments

Drug: GDC-0853

Study type

Interventional

Funder types

Industry

Identifiers

NCT01991184

GO29089

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No 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