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

Not Recruiting

Trial ID: NCT01991184


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.

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

Stanford Investigator(s)

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology


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


drug: GDC-0853

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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