Back to resultsVerubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme
Primary Purpose
Glioblastoma Multiforme
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Verubulin
Temozolomide & Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma, Brain Neoplasms, Brain Cancer, Verubulin
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Sites / Locations
- Stanford University
- University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Verubulin & standard of care (RT & TMZ)
Standard of care (RT & TMZ)
Arm Description
Verubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide
Standard of care Radiation Therapy and Temozolomide
Outcomes
Primary Outcome Measures
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.
Part B: 9 Mo Progression-free survival
Secondary Outcome Measures
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
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01285414
Brief Title
Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title
A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Myrexis Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Glioblastoma, Brain Neoplasms, Brain Cancer, Verubulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verubulin & standard of care (RT & TMZ)
Arm Type
Experimental
Arm Description
Verubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide
Arm Title
Standard of care (RT & TMZ)
Arm Type
Active Comparator
Arm Description
Standard of care Radiation Therapy and Temozolomide
Intervention Type
Drug
Intervention Name(s)
Verubulin
Other Intervention Name(s)
Azixa, MPC-6827
Intervention Description
Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide & Radiation Therapy
Intervention Type
Drug
Intervention Name(s)
Temozolomide & Radiation Therapy
Other Intervention Name(s)
Temodar, TMZ, Radiotherapy
Intervention Description
Temozolomide & Radiation Therapy
Primary Outcome Measure Information:
Title
Part A: Safety
Description
Assess the number and percentage of subjects with adverse events, abnormal laboratory parameters, and ECG changes as measures of safety and tolerability.
Time Frame
14 weeks
Title
Part B: 9 Mo Progression-free survival
Time Frame
9 Month
Secondary Outcome Measure Information:
Title
Part A: Pharmacokinetic Parameters
Description
Measure the amount of verubulin in the body at specific time points when given with standard of care Radiation Therapy and Temozolomide
Time Frame
18 weeks
Title
Part B: 6 Mo Progression Free Survival
Description
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)
Time Frame
6 month
Title
Overall Survival
Description
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)
Time Frame
18 months
Title
Part B: 12 Mo Progression Free Survival
Description
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Beelen, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19296653
Citation
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.
Results Reference
background
PubMed Identifier
17575155
Citation
Kasibhatla 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.
Results Reference
background
PubMed Identifier
21159616
Citation
Tsimberidou 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.
Results Reference
background
Links:
URL
http://www.myrexis.com
Description
Additional Information
Learn more about this trial
Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme
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