Glioblastoma, Glioma
Conditions
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.
Interventions
DRUGGDC-0084
Multiple doses
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | approximately 2 years |
| Maximum tolerated dose (MTD) | approximately 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Duration of response | approximately 2 years |
| Progression-free survival | approximately 2 years |
Countries
Spain, United States
Outcome results
None listed