Back to resultsA Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
Primary Purpose
Glioblastoma, Glioma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GDC-0084
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma, Glioma
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)
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Safety: Incidence of adverse events
Maximum tolerated dose (MTD)
Secondary Outcome Measures
Pharmacokinetics: Area under the concentration-time curve
Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO)
Duration of response
Progression-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01547546
Brief Title
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GDC-0084
Intervention Description
Multiple doses
Primary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
approximately 2 years
Title
Maximum tolerated dose (MTD)
Time Frame
approximately 1 year
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area under the concentration-time curve
Time Frame
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
Title
Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO)
Time Frame
approximately 2 years
Title
Duration of response
Time Frame
approximately 2 years
Title
Progression-free survival
Time Frame
approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32269051
Citation
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.
Results Reference
derived
PubMed Identifier
31937616
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
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