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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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) - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01547546
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Genentech, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Clinical Trials
Principal Investigator Affiliation Genentech, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Glioma
Arms & Interventions

Arms

Experimental: Single Arm

Interventions

Drug: - GDC-0084

Multiple doses

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Address

Los Angeles, California, 90095

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02114

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02115

Houston, Texas

Status

Address

Houston, Texas, 77030

International Sites

Barcelona, Spain

Status

Address

Barcelona, , 08035

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