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

Genentech, Inc.0 sites29 target enrollmentApril 2012

ConditionsGlioblastoma, Glioma

InterventionsGDC-0084

DrugsGDC-0084

Overview

Phase: Phase 1
Intervention: GDC-0084
Conditions: Glioblastoma, Glioma
Sponsor: Genentech, Inc.
Enrollment: 29
Primary Endpoint: Maximum tolerated dose (MTD)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

January 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

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

Arms & Interventions

Single Arm

Intervention: GDC-0084

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD)

Time Frame: approximately 1 year

Safety: Incidence of adverse events

Time Frame: approximately 2 years

Secondary Outcomes

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)