Trial Search Results

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Myrexis Inc.

Stanford Investigator(s):


  • Drug: Verubulin
  • Drug: Temozolomide & Radiation Therapy


Phase 2


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)

Ages Eligible for Study

18 Years - 69 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting