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



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:December 16, 2013
End Date:March 1, 2019

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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

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.


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
We found this trial at
8
sites
Stanford, California 94305
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Eugene, OR
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Nashville, TN
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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Portland, OR
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Woolloongabba,
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