Glioblastoma MultiformePhase 2NCT00892931
Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
A Phase 2 study testing Azixa in people with Glioblastoma Multiforme, run by Myrexis Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme 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?
- Azixa
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 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
- Have histologically proven malignant Glioblastoma Multiforme in first or second relapse
- Have failed prior Fractionated External Beam Cranial Irradiation or IMRT
- Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy
- Have a Karnofsky performance status of ≥ 60
- Have adequate bone marrow function, liver function, and renal function before starting therapy
Who cannot join
- Have had more than two relapses
- Have had radiosurgery
- Have a cardiac ejection fraction < 50% by MUGA or ECHO
- Have Troponin-I elevated above the normal range
- Have an increasing steroid requirement
- Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage
Show all 11Show fewer
- Have active stroke and/or transient ischemic attack not optimally managed
- Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension)
- Be pregnant or breast feeding
- Have had prior hypersensitivity reaction to Cremophor EL
- Be HIV positive
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Lahey Clinic
Burlington, Massachusetts, 01805
Northwestern University
Chicago, Illinois, 60611
Darthmouth -Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Columbia University
New York, New York, 10032
Barrow Neurological Institute
Phoenix, Arizona, 85013
SCCA/University of Washington
Seattle, Washington, 981209
Stanford University
Stanford, California, 94305
University of Massachusettes
Worcester, Massachusetts, 01655
About this study
Official title: Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
- Conditions
- Glioblastoma Multiforme
- Being tested
- Azixa
- Keywords
- Glioblastoma, Brain Neoplasms, Recurrence
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzixaDrug
Also called MPC-6827
3.3 mg/m2 of Azixa administered by intravenous infusion over 2 hours once weekly for 3 consecutive weeks every 4 weeks (1 cycle = 4 weeks)
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the progression-free survival (PFS) rate
Measured: Six 28-day cycles from start of therapy
Secondary outcomes (2)
Overall survival
Measured: 36 months
Overall response rate
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
- Study completionSep 2011
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 MultiformeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myrexis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Beelen, MD, Study director, Myrexis Inc.Lawrence Recht, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892931
- Sponsor's protocol ID
- MPC-6827-019
- Status last verified
- Oct 2011
- First submitted
- 3 May 2009
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sirisoma N, Pervin A, Zhang H, Jiang S, Willardsen JA, Anderson MB, Mather G, Pleiman CM, Kasibhatla S, Tseng B, Drewe J, Cai SX. Discovery of N-(4-methoxyphenyl)-N,2-dimethylquinazolin-4-amine, a potent apoptosis inducer and efficacious anticancer agent with high blood brain barrier penetration. J Med Chem. 2009 Apr 23;52(8):2341-51. doi: 10.1021/jm801315b.
PubMed 19296653Kasibhatla S, Baichwal V, Cai SX, Roth B, Skvortsova I, Skvortsov S, Lukas P, English NM, Sirisoma N, Drewe J, Pervin A, Tseng B, Carlson RO, Pleiman CM. MPC-6827: a small-molecule inhibitor of microtubule formation that is not a substrate for multidrug resistance pumps. Cancer Res. 2007 Jun 15;67(12):5865-71. doi: 10.1158/0008-5472.CAN-07-0127.
PubMed 17575155
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00892931
- Acronym / sponsor ID
- MPC-6827-019
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma, Brain Neoplasms, Recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 May 2009 (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.
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have histologically proven malignant Glioblastoma Multiforme in first or second relapse
- Have failed prior Fractionated External Beam Cranial Irradiation or IMRT
- Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy
- Have a Karnofsky performance status of ≥ 60
- Have adequate bone marrow function, liver function, and renal function before starting therapy
Key exclusion criteria (11 listed)
- Have had more than two relapses
- Have had radiosurgery
- Have a cardiac ejection fraction < 50% by MUGA or ECHO
- Have Troponin-I elevated above the normal range
- Have an increasing steroid requirement
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 |
|---|---|---|
| AzixaAlso: MPC-68273.3 mg/m2 of Azixa administered by intravenous infusion over 2 hours once weekly for 3 consecutive weeks every 4 weeks (1 cycle = 4 weeks) | Drug | – |
Primary outcome
To determine the progression-free survival (PFS) rate
Time frame: Six 28-day cycles from start of therapy
2 secondary outcomes
Overall survival
Time frame: 36 months
Overall response rate
Time frame: 18 months
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 14 Oct 2011.
- Background: PubMed 19296653Sirisoma N, Pervin A, Zhang H, Jiang S, Willardsen JA, Anderson MB, Mather G, Pleiman CM, Kasibhatla S, Tseng B, Drewe J, Cai SX. Discovery of N-(4-methoxyphenyl)-N,2-dimethylquinazolin-4-amine, a potent apoptosis inducer and efficacious anticancer agent with high blood brain barrier penetration. J Med Chem. 2009 Apr 23;52(8):2341-51. doi: 10.1021/jm801315b.
- Background: PubMed 17575155Kasibhatla S, Baichwal V, Cai SX, Roth B, Skvortsova I, Skvortsov S, Lukas P, English NM, Sirisoma N, Drewe J, Pervin A, Tseng B, Carlson RO, Pleiman CM. MPC-6827: a small-molecule inhibitor of microtubule formation that is not a substrate for multidrug resistance pumps. Cancer Res. 2007 Jun 15;67(12):5865-71. doi: 10.1158/0008-5472.CAN-07-0127.
- Myriad Pharmaceuticals Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing novel small molecule drugs that address severe medical conditions, including cancer and HIV infection.Link provided by the sponsor.
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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.
Andrew Beelen, MD study director
Myrexis Inc.
Lawrence Recht, MD principal investigator
Stanford University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azixa in people with Glioblastoma Multiforme, run by Myrexis Inc. at 10 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 11 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 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 phase mean?
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?
To determine the progression-free survival (PFS) rate (time frame: Six 28-day cycles from start of therapy). 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 NCT00892931, 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 14 Oct 2011.