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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01547546
First received: March 5, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label, multicenter, Phase I, dose-escalating study will evaluate the s afety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0 084 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 Intervention Phase
Glioblastoma, Glioma
Drug: GDC-0084
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-0084 Administered to Patients With Progressive or Recurrent High-grade Glioma

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose (MTD) [ Time Frame: approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Duration of response [ 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: 68
Study Start Date: April 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: GDC-0084
Multiple doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01547546

Contacts
Contact: Reference Study ID Number: GO28070 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
Los Angeles, California, United States, 90095
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
Recruiting
Boston, Massachusetts, United States, 02114
United States, Texas
Not yet recruiting
Houston, Texas, United States, 77030
Spain
Recruiting
Barcelona, Spain, 08035
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01547546     History of Changes
Other Study ID Numbers: GO28070, 2011-004479-35
Study First Received: March 5, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 22, 2014