A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
- Registration Number
- NCT01547546
- Lead Sponsor
- Genentech, Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm GDC-0084 -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) approximately 1 year Safety: Incidence of adverse events approximately 2 years
- Secondary Outcome Measures
Name Time Method Duration of response approximately 2 years Pharmacokinetics: Area under the concentration-time curve 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) approximately 2 years Progression-free survival approximately 2 years