Select Your Region
Global
Find participating medical centers and current study status in each of them
Find participating medical centers
-
Home
-
Search Results
- Clinical Trial Details
A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
Cancer Non Hodgkin Lymphoma (NHL) Diffuse Large B-Cell Lymphoma (DLBCL) Leukemia Chronic Lymphocytic Leukemia
Basic Details
Sponsor
Genentech, Inc. (Part of F. Hoffmann-La Roche Ltd., Switzerland)
Phase
Phase 1
Trial Identifier
NCT01991184, GO29089
Condition
Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
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
Study Summary
This clinical trial was done to study a new medicine (fenebrutinib) for the treatment of patients with blood cancer. This was a phase 1, dose-escalation study to find out which dose of fenebrutinib was safe and tolerable for people with B-cell non-Hodgkin’s lymphoma (B-NHL) and chronic lymphocytic leukemia (B-CLL). Twenty-four people with B-NHL or B-CLL – that had come back (relapsed) or did not respond to medicine (refractory) – where the disease had gotten worse (progressed) even after getting available medicines – and for which no other effective medicine was available – took part in this study. The study took place at nine study centers in two countries – USA and Australia.
Eligibility Criteria
All
≥18 Years
No
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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
Explore related studies
For the latest version of this information please go to www.forpatients.roche.com