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A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma

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

NCT01547546•Genentech, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+1 more criteria

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

Locations (5)

Los Angeles, California, United States

Boston, Massachusetts, United States

Houston, Texas, United States

Barcelona, Barcelona, Spain

Key Dates

Start Date

April 1, 2012

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Glioblastoma, Glioma

Interventions

GDC-0084

DRUG