Overview

This trial is active, not recruiting.

Condition lymphocytic leukemia, chronic, diffuse large b-cell lymphoma
Treatment gdc-0853
Phase phase 1
Sponsor Genentech, Inc.
Start date December 2013
End date January 2017
Trial size 24 participants
Trial identifier NCT01991184, GO29089

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
gdc-0853
Multiple escalating doses

Primary Outcomes

Measure
Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
time frame: Approximately 1 year
Safety: Maximum tolerated dose (MTD) of GDC-0853
time frame: Approximately 1 year

Secondary Outcomes

Measure
Safety: Incidence of adverse events
time frame: Approximately 2 years
Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853
time frame: 35 days
Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853
time frame: 35 days
Objective response to GDC-0853
time frame: Approximately 2 years
Progression-free survival
time frame: Approximately 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..