Glioblastoma, Glioma Clinical Trial
Official title:
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
| Verified date | November 2016 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: Incidence of adverse events | approximately 2 years | Yes | |
| Primary | Maximum tolerated dose (MTD) | approximately 1 year | Yes | |
| Secondary | 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 | No | |
| Secondary | Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO) | approximately 2 years | No | |
| Secondary | Duration of response | approximately 2 years | No | |
| Secondary | Progression-free survival | approximately 2 years | No |