A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
Status: Recruiting
Phase:
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT01547546
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-492
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital
Overall PI:
Patrick Wen, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Elizabeth Gerstner, MD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Lisa Doherty,
ldoherty1@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility 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