Glioblastoma MultiformePhase 2NCT01285414
Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 2 study testing Verubulin and Temozolomide & Radiation Therapy in people with Glioblastoma Multiforme, run by Myrexis Inc. at 2 sites in United States.
Trial summary
This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Verubulin and Temozolomide & Radiation Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Mar 2012
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically proven, newly diagnosed glioblastoma multiforme
- Age ≥ 18 years and < 70 years
- Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 70
- Have adequate bone marrow function , liver function, and kidney function before starting therapy
- Begin study therapy no more than 6 weeks after surgery or biopsy
- Subjects that have had surgery must have an MRI ≤ 72 hours after surgery
Who cannot join
- Have a carmustine implant (e.g., Gliadel® Wafer)
- Have uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg for more than 1 week)
- Have a left ventricular ejection fraction below the lower limit of the reference range for the institution, as measured by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
- Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution
- Have an increasing steroid requirement, indicative of a rapidly progressive disease
- Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 2
Show all 12Show fewer
- Have had prior cranial radiotherapy
- Have history of stroke and/or transient ischemic attack within 2 years of screening
- Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening
- Be pregnant or breast feeding
- Have a history of hypersensitivity reaction to Cremophor® EL
- Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Stanford University
Stanford, California, 94305
About this study
Official title: A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme
This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Verubulin, Temozolomide & Radiation Therapy
- Keywords
- Glioblastoma, Brain Neoplasms, Brain Cancer, Verubulin
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerubulinDrug
Also called Azixa, MPC-6827
Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide \& Radiation Therapy
Temozolomide & Radiation TherapyDrug
Also called Temodar, TMZ, Radiotherapy
Temozolomide \& Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Verubulin & standard of care (RT & TMZ) | Experimental | Verubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide Receives: Drug: Verubulin |
| Standard of care (RT & TMZ) | Active comparator | Standard of care Radiation Therapy and Temozolomide Receives: Drug: Temozolomide & Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety
Assess the number and percentage of subjects with adverse events, abnormal laboratory parameters, and ECG changes as measures of safety and tolerability.
Measured: 14 weeks
Part B: 9 Mo Progression-free survival
Measured: 9 Month
Secondary outcomes (4)
Part A: Pharmacokinetic Parameters
Measure the amount of verubulin in the body at specific time points when given with standard of care Radiation Therapy and Temozolomide
Measured: 18 weeks
Part B: 6 Mo Progression Free Survival
Assess 6-month progression-free survival and compare median progression-free survival time for Radiation Therapy plus Temozolomide (TMZ)plus verubulin to standard of care (Radiation Therapy plus TMZ alone)
Measured: 6 month
Overall Survival
Assess overall survival and compare median overall survival time for Radiation Therapy plus Temozolomide (TMZ)plus verubulin to standard of care (Radiation Therapy plus TMZ alone)
Measured: 18 months
Part B: 12 Mo Progression Free Survival
Assess 12-month progression-free survival and compare median progression-free survival time for Radiation Therapy plus Temozolomide (TMZ)plus verubulin to standard of care (Radiation Therapy plus TMZ alone)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285414
- Sponsor's protocol ID
- MPC-6827-021
- Status last verified
- Apr 2012
- First submitted
- 14 Jan 2011
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 17575155Tsimberidou AM, Akerley W, Schabel MC, Hong DS, Uehara C, Chhabra A, Warren T, Mather GG, Evans BA, Woodland DP, Swabb EA, Kurzrock R. Phase I clinical trial of MPC-6827 (Azixa), a microtubule destabilizing agent, in patients with advanced cancer. Mol Cancer Ther. 2010 Dec;9(12):3410-9. doi: 10.1158/1535-7163.MCT-10-0516.
PubMed 21159616
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01285414
- Acronym / sponsor ID
- MPC-6827-021
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma, Brain Neoplasms, Brain Cancer, Verubulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Jan 2011 (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, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verubulin & standard of care (RT & TMZ) | Experimental | Drug: VerubulinVerubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide |
| Standard of care (RT & TMZ) | Active comparator | Drug: Temozolomide & Radiation TherapyStandard of care Radiation Therapy and Temozolomide |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have histologically proven, newly diagnosed glioblastoma multiforme
- Age ≥ 18 years and < 70 years
- Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 70
- Have adequate bone marrow function , liver function, and kidney function before starting therapy
- Begin study therapy no more than 6 weeks after surgery or biopsy
Key exclusion criteria (12 listed)
- Have a carmustine implant (e.g., Gliadel® Wafer)
- Have uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg for more than 1 week)
- Have a left ventricular ejection fraction below the lower limit of the reference range for the institution, as measured by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
- Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution
- Have an increasing steroid requirement, indicative of a rapidly progressive 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 |
|---|---|---|
| VerubulinAlso: Azixa, MPC-6827Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide \& Radiation Therapy | Drug | Verubulin & standard of care (RT & TMZ) |
| Temozolomide & Radiation TherapyAlso: Temodar, TMZ, RadiotherapyTemozolomide \& Radiation Therapy | Drug | Standard of care (RT & TMZ) |
Primary outcome
Part A: Safety
Time frame: 14 weeks
Assess the number and percentage of subjects with adverse events, abnormal laboratory parameters, and ECG changes as measures of safety and tolerability.
Part B: 9 Mo Progression-free survival
Time frame: 9 Month
4 secondary outcomes
Part A: Pharmacokinetic Parameters
Time frame: 18 weeks
Part B: 6 Mo Progression Free Survival
Time frame: 6 month
Overall Survival
Time frame: 18 months
Part B: 12 Mo Progression Free Survival
Time frame: 12 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 11 Apr 2012.
- 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.
- Background: PubMed 21159616Tsimberidou AM, Akerley W, Schabel MC, Hong DS, Uehara C, Chhabra A, Warren T, Mather GG, Evans BA, Woodland DP, Swabb EA, Kurzrock R. Phase I clinical trial of MPC-6827 (Azixa), a microtubule destabilizing agent, in patients with advanced cancer. Mol Cancer Ther. 2010 Dec;9(12):3410-9. doi: 10.1158/1535-7163.MCT-10-0516.
- Additional InformationLink provided by the sponsor.
Related trials for Glioblastoma Multiforme
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
2 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 Verubulin and Temozolomide & Radiation Therapy in people with Glioblastoma Multiforme, run by Myrexis Inc. at 2 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 12 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 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Part A: Safety (time frame: 14 weeks). 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 NCT01285414, which also lists 3 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 11 Apr 2012.