Glioblastoma, GliomaPhase 1NCT01547546
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
A Phase 1 study testing GDC-0084 in people with Glioblastoma, Glioma, run by Genentech, Inc. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioma
- What is being tested?
- GDC-0084
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Apr 2012to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02115
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90095
About this study
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
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.
- Conditions
- Glioblastoma, Glioma
- Being tested
- GDC-0084
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0084Drug
Multiple doses
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: GDC-0084 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: approximately 2 years
Maximum tolerated dose (MTD)
Measured: approximately 1 year
Secondary outcomes (4)
Pharmacokinetics: Area under the concentration-time curve
Measured: 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
Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO)
Measured: approximately 2 years
Duration of response
Measured: approximately 2 years
Progression-free survival
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma, GliomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547546
- Sponsor's protocol ID
- GO28070
- Other IDs
- 2011-004479-35
- Status last verified
- Nov 2016
- First submitted
- 5 Mar 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
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.
PubMed 32269051Wen 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.
PubMed 31937616
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01547546
- Acronym / sponsor ID
- GO28070
- Conditions
- Glioblastoma, Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: GDC-0084 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-0084Multiple doses | Drug | Single Arm |
Primary outcome
Safety: Incidence of adverse events
Time frame: approximately 2 years
Maximum tolerated dose (MTD)
Time frame: approximately 1 year
4 secondary outcomes
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
Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO)
Time frame: approximately 2 years
Duration of response
Time frame: approximately 2 years
Progression-free survival
Time frame: approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 32269051Ellingson 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.
- Derived from this study: PubMed 31937616Wen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0084 in people with Glioblastoma, Glioma, run by Genentech, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of adverse events (time frame: approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547546, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.