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A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01547546
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.

Condition or disease Intervention/treatment Phase
Glioblastoma, Glioma Drug: GDC-0084 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase I, Dose-escalation Study Evaluating the Safety and Tolerability of GDC-0084 Administered to Patients With Progressive or Recurrent High-grade Glioma
Study Start Date : April 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm Drug: GDC-0084
Multiple doses


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]
  2. Maximum tolerated dose (MTD) [ Time Frame: approximately 1 year ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre- and post-dose Days 1, 8, 15, 22 and 29 Cycle 1, Day 1 every following Cycle until 30 days after the last dose of study drug ]
  2. Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO) [ Time Frame: approximately 2 years ]
  3. Duration of response [ Time Frame: approximately 2 years ]
  4. Progression-free survival [ Time Frame: approximately 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to study entry
  • Karnofsky Performance Status of >/= 70 at screening
  • Confirmed measurable disease per RANO
  • Adequate hematologic and organ function

Patients enrolled in Stage 1:

  • Histologically documented recurrent or progressive high-grade gliomas (WHO Grade III-IV)
  • Prior treatment with at least one regimen for gliomas (radiotherapy with or without chemotherapy for Grade III gliomas and radiotherapy with chemotherapy for Grade IV gliomas) and/or not considered to be a candidate for regimens known to provide clinical benefit

Patients enrolled in Stage 2:

  • Histologically documented recurrent or progressive glioblastoma (WHO Grade IV gliomas)
  • Prior treatment with one or two regimens for glioblastoma (with the initial regimen consisting of radiotherapy with chemotherapy)

Exclusion Criteria:

  • Treatment with anti-tumor therapy (approved or experimental) within 4 weeks prior to initiation of study drug
  • Requirement for anticoagulants such as warfarin or any other warfarin-derivative anticoagulants; low-molecular-weight heparin is permitted
  • Any contraindication to MRI examination
  • Evidence of Grade >/= 1 intracranial hemorrhage
  • Active congestive heart failure or ventricular arrhythmia requiring medication
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse or cirrhosis
  • Unresolved toxicity from prior therapy with the exception of lymphopenia (for patients with prior temozolomide) and alopecia
  • Pregnant or lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547546


Locations
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United States, California
Los Angeles, California, United States, 90095
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
United States, Texas
Houston, Texas, United States, 77030
Spain
Barcelona, Spain, 08035
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01547546    
Other Study ID Numbers: GO28070
2011-004479-35 ( EudraCT Number )
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
GDC-0084
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action