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

Study Overview
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Brief Summary
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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
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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

Conditions
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Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma

Intervention / Treatment
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* Drug: GDC-0853


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose-escalation<br> | Drug: GDC-0853<br>* Multiple escalating doses<br>* Other names: Fenebrutinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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