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

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

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.

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