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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT01285414
First received: January 14, 2011
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Glioblastoma Multiforme
Drug: Verubulin
Drug: Temozolomide & Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Part A: Safety [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 9 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part A: Pharmacokinetic Parameters [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 5
Study Start Date: December 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285414

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Andrew Beelen, MD Myrexis Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Myrexis Inc.
ClinicalTrials.gov Identifier: NCT01285414     History of Changes
Other Study ID Numbers: MPC-6827-021
Study First Received: January 14, 2011
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:
Glioblastoma
Brain Neoplasms
Brain Cancer
Verubulin

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014