Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
Conditions
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.
Interventions
DRUGGDC-0853
Multiple escalating doses
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853 | 35 days |
| Safety: Incidence of adverse events | Approximately 2 years |
| Progression-free survival | Approximately 2 years |
| Objective response to GDC-0853 | Approximately 2 years |
| Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853 | 35 days |
Countries
Australia, United States
Outcome results
None listed