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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01991184
First received: November 18, 2013
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This open-label, Phase I study will evaluate the safety, tolerability, and pharm acokinetics of increasing doses of GDC-0853 in patients with relapsed or refract ory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-exp ansion part, GDC-0853 will be assessed in subsets of patients.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic, Lymphoma, B-Cell
Drug: GDC-0853
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
  • Safety: Maximum tolerated dose (MTD) of GDC-0853 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • Objective response to GDC-0853 [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 121
Study Start Date: December 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-escalation Drug: GDC-0853
Multiple escalating doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991184

Contacts
Contact: Reference Study ID Number: GO29089 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
Stanford, California, United States, 94305-5820
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
United States, Ohio
Recruiting
Columbus, Ohio, United States, 43212
United States, Oregon
Recruiting
Eugene, Oregon, United States, 97401-8122
Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
United States, Washington
Recruiting
Seattle, Washington, United States, 98109
Australia, Queensland
Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Recruiting
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01991184     History of Changes
Other Study ID Numbers: GO29089
Study First Received: November 18, 2013
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, B-Cell
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 21, 2014