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

Completed · Phase 1

Conditions studied: Glioblastoma, Glioma

In brief

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.

Key facts

Study ID

NCT01547546

Run by

Genentech, Inc.

People needed

29

Starts

2012-04-01

Expected to finish

2015-01-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Houston, Texas, United States
• Study site — Barcelona, Barcelona, Spain

Full record on ClinicalTrials.gov

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