A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or 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.
Checked against the public recordLast updated Jun 21, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: GDC-0853
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Stanford Cancer CenterStanford, California
- Washington University School of MedicineSt Louis, Missouri
- The Ohio State University Wexner Medical CenterColumbus, Ohio
- Willamette Valley Cancer Ctr - 520 Country ClubEugene, Oregon
- Oregon Health Sciences UniPortland, Oregon
- Sarah Cannon Cancer Center - Tennessee Oncology, PllcNashville, Tennessee
- Seattle Cancer Care AllianceSeattle, Washington
- Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical OncologyWoolloongabba, Queensland
- Peter MacCallum Cancer Centre; Department of HaematologyMelbourne, Victoria
- Linear Clinical Research LimitedNedlands, Western Australia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 21, 2022. Always confirm current availability with the study team.