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

Phase 2

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Verubulin; Drug: Temozolomide & Radiation Therapy

• Registration Number: NCT01285414
• Lead Sponsor: Myrexis Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-28
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Have histologically proven, newly diagnosed glioblastoma multiforme
2. Age ≥ 18 years and < 70 years
3. Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 70
4. Have adequate bone marrow function , liver function, and kidney function before starting therapy
5. Begin study therapy no more than 6 weeks after surgery or biopsy
6. Subjects that have had surgery must have an MRI ≤ 72 hours after surgery

Exclusion Criteria

1. Have a carmustine implant (e.g., Gliadel® Wafer)
2. Have uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg for more than 1 week)
3. 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)
4. Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution
5. Have an increasing steroid requirement, indicative of a rapidly progressive disease
6. Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 2
7. Have had prior cranial radiotherapy
8. Have history of stroke and/or transient ischemic attack within 2 years of screening
9. Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening
10. Be pregnant or breast feeding
11. Have a history of hypersensitivity reaction to Cremophor® EL
12. Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verubulin & standard of care (RT & TMZ)	Verubulin	Verubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide
Standard of care (RT & TMZ)	Temozolomide & Radiation Therapy	Standard of care Radiation Therapy and Temozolomide

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (2)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Stanford University; 🇺🇸 Stanford, California, United States