A study to look at how safe was it to give people with blood cancer (non-Hodgkin’s lymphoma and chronic lymphocytic leukemia) – different doses of a study medicine (fenebrutinib)

  • Diffuse Large B-Cell Lymphoma
  • Chronic Lymphocytic Leukemia
Trial Status:

Completed

This trial runs in
Countries
  • Australia
  • United States
Trial Identifier:

NCT01991184 GO29089

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      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 trial 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 below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial 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.

      Genentech, Inc. (Part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 1 Phase
      NCT01991184 , GO29089 Trial Identifier
      Fenebrutinib Treatments
      Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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