Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma Clinical Trial
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
| Verified date | June 2022 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | March 8, 2022 |
| Est. primary completion date | March 8, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Peter MacCallum Cancer Centre; Department of Haematology | Melbourne | Victoria |
| Australia | Linear Clinical Research Limited | Nedlands | Western Australia |
| Australia | Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology | Woolloongabba | Queensland |
| United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
| United States | Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon |
| United States | Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee |
| United States | Oregon Health Sciences Uni | Portland | Oregon |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Stanford Cancer Center | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853 | Approximately 1 year | ||
| Primary | Safety: Maximum tolerated dose (MTD) of GDC-0853 | Approximately 1 year | ||
| Secondary | Safety: Incidence of adverse events | Approximately 2 years | ||
| Secondary | Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853 | 35 days | ||
| Secondary | Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853 | 35 days | ||
| Secondary | Objective response to GDC-0853 | Approximately 2 years | ||
| Secondary | Progression-free survival | Approximately 2 years |