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
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