A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
Status: | Completed |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2016 |
Start Date: | April 2012 |
End Date: | January 2015 |
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
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.
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.
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
We found this trial at
5
sites
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
