A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
NCT ID: NCT01547546
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2012-04-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
GDC-0084
Multiple doses
Interventions
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GDC-0084
Multiple doses
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Los Angeles, California, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Houston, Texas, United States
Barcelona, Barcelona, Spain
Countries
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References
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Ellingson BM, Yao J, Raymond C, Nathanson DA, Chakhoyan A, Simpson J, Garner JS, Olivero AG, Mueller LU, Rodon J, Gerstner E, Cloughesy TF, Wen PY. Multiparametric MR-PET Imaging Predicts Pharmacokinetics and Clinical Response to GDC-0084 in Patients with Recurrent High-Grade Glioma. Clin Cancer Res. 2020 Jul 1;26(13):3135-3144. doi: 10.1158/1078-0432.CCR-19-3817. Epub 2020 Apr 8.
Wen PY, Cloughesy TF, Olivero AG, Morrissey KM, Wilson TR, Lu X, Mueller LU, Coimbra AF, Ellingson BM, Gerstner E, Lee EQ, Rodon J. First-in-Human Phase I Study to Evaluate the Brain-Penetrant PI3K/mTOR Inhibitor GDC-0084 in Patients with Progressive or Recurrent High-Grade Glioma. Clin Cancer Res. 2020 Apr 15;26(8):1820-1828. doi: 10.1158/1078-0432.CCR-19-2808. Epub 2020 Jan 14.
Other Identifiers
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2011-004479-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO28070
Identifier Type: -
Identifier Source: org_study_id