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


Phase 2
18 Years
69 Years
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part A: Safety

Outcome Description:

Assess the number and percentage of subjects with adverse events, abnormal laboratory parameters, and ECG changes as measures of safety and tolerability.

Outcome Time Frame:

14 weeks

Safety Issue:

Yes

Principal Investigator

Andrew Beelen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Myrexis Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MPC-6827-021

NCT ID:

NCT01285414

Start Date:

December 2010

Completion Date:

March 2012

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma
  • Brain Neoplasms
  • Brain Cancer
  • Verubulin
  • Glioblastoma

Name

Location

Stanford UniversityStanford, California  94305
University of Texas Health Science Center at HoustonHouston, Texas  77225