Glioblastoma MultiformePhase 1/2NCT00635557
Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
A Phase 1/2 study testing MPC-6827 + Carboplatin in people with Glioblastoma Multiforme, run by Myrexis Inc. at 5 sites in United States.
Trial summary
This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. 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?
- MPC-6827 + Carboplatin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2008to Aug 2011
- 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 proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
- Prior treatment with radiotherapy and temozolomide
- Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
- Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
- Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2
- If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week
Who cannot join
- Hypersensitivity to Cremophor EL
- Have evidence of current/active intratumor hemorrhage by MRI
- Have greater than second relapse
- Have had prior treatment with platinum-based chemotherapy
- Have cardiovascular disease
- Have cerebrovascular disease
Show all 9Show fewer
- Have uncontrolled hypertension
- Have a cardiac ejection fraction < 50%
- Have Troponin-I elevated above the normal range
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Mt. Sinai School of Medicine
New York, New York, 10029
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin
This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.
- Conditions
- Glioblastoma Multiforme
- Being tested
- MPC-6827 + Carboplatin
- Keywords
- Recurrent, Relapsed, Glioblastoma, Multiforme
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPC-6827 + CarboplatinDrug
MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: After each cohort is enrolled and all subjects have completed 1 cycle
Secondary outcomes (2)
Pharmacokinetics
Measured: Cycle 1 only
Antitumor activity
Measured: Screening, end of each cycle, end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2010
- Study completionAug 2011 (estimated)
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myrexis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew P. Beelen, MD, Study director, Myrexis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635557
- Sponsor's protocol ID
- MPC-6827-07-004
- Other IDs
- MPC-6827 GBM
- Status last verified
- Mar 2011
- First submitted
- 6 Mar 2008
- Last updated
- 25 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin
- ClinicalTrials.gov ID
- NCT00635557
- Acronym / sponsor ID
- MPC-6827-07-004
- Conditions
- Glioblastoma Multiforme
- Keywords
- Recurrent, Relapsed, Glioblastoma, Multiforme
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Aug 2011 (estimated)
- First posted
- 13 Mar 2008 (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 is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.
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 (6 listed)
- Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
- Prior treatment with radiotherapy and temozolomide
- Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
- Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
- Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2
Key exclusion criteria (9 listed)
- Hypersensitivity to Cremophor EL
- Have evidence of current/active intratumor hemorrhage by MRI
- Have greater than second relapse
- Have had prior treatment with platinum-based chemotherapy
- Have cardiovascular disease
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 |
|---|---|---|
| MPC-6827 + CarboplatinMPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle. | Drug | – |
Primary outcome
Maximum tolerated dose
Time frame: After each cohort is enrolled and all subjects have completed 1 cycle
2 secondary outcomes
Pharmacokinetics
Time frame: Cycle 1 only
Antitumor activity
Time frame: Screening, end of each cycle, end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
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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 P. Beelen, MD study director
Myrexis Inc.
5 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 MPC-6827 + Carboplatin in people with Glioblastoma Multiforme, run by Myrexis Inc. at 5 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Mar 2011. 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. 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?
Results are not available in the source record.
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: After each cohort is enrolled and all subjects have completed 1 cycle). 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 25 Mar 2011.