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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.

Tracking Information
First Submitted Date  ICMJE March 5, 2012
First Posted Date  ICMJE March 8, 2012
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]
  • Maximum tolerated dose (MTD) [ Time Frame: approximately 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
  • 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 ]
  • Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO) [ Time Frame: approximately 2 years ]
  • Duration of response [ Time Frame: approximately 2 years ]
  • Progression-free survival [ Time Frame: approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma, Glioma
Intervention  ICMJE Drug: GDC-0084
Multiple doses
Study Arms  ICMJE Experimental: Single Arm
Intervention: Drug: GDC-0084
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)
29
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2012)
68
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547546
Other Study ID Numbers  ICMJE GO28070
2011-004479-35 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP