Glioblastoma MultiformePhase 1/2NCT00116376
Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)
A Phase 1/2 study testing AEE788 in people with Glioblastoma Multiforme, run by Novartis Pharmaceuticals at 4 sites in United States.
Trial summary
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- AEE788
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2004to Nov 2005
- Phase
- Phase 1/2
- 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
- Histologically confirmed GBM in first or second recurrence or relapse
- Adequate hematologic, hepatic and renal function
- Age ≥ 18 years
- Karnofsky performance status score ≥ 70%
- Life expectancy ≥ 12 weeks
Who cannot join
- Peripheral neuropathy > grade 1
- Diarrhea > grade 1
- Gastrointestinal dysfunction
- Compromised cardiac function
- Concurrent severe and/or uncontrolled medical conditions
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Brain Tumor Center at Duke, Duke University Medical Center
Box 3624 Dumc, Trent Drive, Durham, North Carolina, 27710
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
University of California at Los Angeles
Los Angeles, California, 90095
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.
- Conditions
- Glioblastoma Multiforme
- Being tested
- AEE788
- Keywords
- GBM, recurrent/relapse, EGFR, VEGFR
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEE788Drug
| Study group | Role | What they receive |
|---|---|---|
| AEE788 + non EIACD | Experimental | Not described Receives: Drug: AEE788 |
| AEE788 + EIACD | Experimental | Not described Receives: Drug: AEE788 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 2 years
Dose limiting toxicity
Measured: 2 years
Secondary outcomes (1)
Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2005 (estimated)
- Study startJan 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Reardon, MD, Principal investigator, Duke UniversityCharles Conrad, MD, Principal investigator, M.D. Anderson Cancer CenterTimothy Cloughesy, MD, Principal investigator, University of California, Los AngelesMichael Prados, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116376
- Sponsor's protocol ID
- CAEE788A2103
- Status last verified
- Nov 2015
- First submitted
- 28 Jun 2005
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00116376
- Acronym / sponsor ID
- CAEE788A2103
- Conditions
- Glioblastoma Multiforme
- Keywords
- GBM, recurrent/relapse, EGFR, VEGFR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 29 Jun 2005 (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.
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEE788 + non EIACD | Experimental | Drug: AEE788 |
| AEE788 + EIACD | Experimental | Drug: AEE788 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed GBM in first or second recurrence or relapse
- Adequate hematologic, hepatic and renal function
- Age ≥ 18 years
- Karnofsky performance status score ≥ 70%
- Life expectancy ≥ 12 weeks
Key exclusion criteria (5 listed)
- Peripheral neuropathy > grade 1
- Diarrhea > grade 1
- Gastrointestinal dysfunction
- Compromised cardiac function
- Concurrent severe and/or uncontrolled medical conditions
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 |
|---|---|---|
| AEE788 | Drug | AEE788 + EIACD, AEE788 + non EIACD |
Primary outcome
Maximum tolerated dose
Time frame: 2 years
Dose limiting toxicity
Time frame: 2 years
1 secondary outcome
Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels
Time frame: 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 10 Nov 2015.
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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.
David Reardon, MD principal investigator
Duke University
Charles Conrad, MD principal investigator
M.D. Anderson Cancer Center
Timothy Cloughesy, MD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AEE788 in people with Glioblastoma Multiforme, run by Novartis Pharmaceuticals at 4 sites in United States.
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 5 inclusion and 5 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Maximum tolerated dose (time frame: 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?
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 10 Nov 2015.