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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 69 Years
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01285414
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Myrexis Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andrew Beelen, MD
Principal Investigator Affiliation	Myrexis Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme
Study Website:	View Trial Website

Arms & Interventions

Arms

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

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

Active Comparator: Standard of care (RT & TMZ)

Standard of care Radiation Therapy and Temozolomide

Interventions

Drug: - Verubulin

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

Drug: - Temozolomide & Radiation Therapy

Temozolomide & Radiation Therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Stanford, California

Status

Address

Stanford University

Stanford, California, 94305

Houston, Texas