Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme

Sponsor

Myrexis Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01285414

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Drug: Verubulin Drug: Temozolomide & Radiation Therapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Verubulin & standard of care (RT & TMZ) Verubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide	Drug: Verubulin Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide & Radiation Therapy Other Names: Azixa MPC-6827
Active Comparator: Standard of care (RT & TMZ) Standard of care Radiation Therapy and Temozolomide	Drug: Temozolomide & Radiation Therapy Temozolomide & Radiation Therapy Other Names: Temodar TMZ Radiotherapy

Arm

Intervention/Treatment

Experimental: Verubulin & standard of care (RT & TMZ)

Verubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide

Drug: Verubulin

Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide & Radiation Therapy

Other Names:

Azixa

MPC-6827

Active Comparator: Standard of care (RT & TMZ)

Standard of care Radiation Therapy and Temozolomide

Drug: Temozolomide & Radiation Therapy

Temozolomide & Radiation Therapy

Other Names:

Temodar

TMZ

Radiotherapy

Outcome Measures

Primary Outcome Measures

Part A: Safety [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 [9 Month]

Secondary Outcome Measures

Part A: Pharmacokinetic Parameters [18 weeks]
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 [6 month]
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 [18 months]
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 [12 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)