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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Verubulin & standard of care (RT & TMZ)

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

Group Type EXPERIMENTAL

Verubulin

Intervention Type DRUG

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

Standard of care (RT & TMZ)

Standard of care Radiation Therapy and Temozolomide

Group Type ACTIVE_COMPARATOR

Temozolomide & Radiation Therapy

Intervention Type DRUG

Temozolomide \& Radiation Therapy

Interventions

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Verubulin

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

Intervention Type DRUG

Temozolomide & Radiation Therapy

Temozolomide \& Radiation Therapy

Intervention Type DRUG

Other Intervention Names

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Azixa MPC-6827 Temodar TMZ Radiotherapy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No