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Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

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Trial Information

Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme


I. Determine the therapeutic efficacy of dasatinib, in terms of 6-month progression-free
survival, in all patients (i.e., stage 1B [closed to accrual as of 4/14/2009] and stage 2
[closed to accrual as of 4/14/2009] combined) with recurrent/progressive glioblastoma
multiforme or gliosarcoma.


I. Determine the therapeutic efficacy of this drug, in terms of a hybrid endpoint of 6-month
progression-free survival or objective response (complete or partial) rate, in patients in
stage 1B (closed to accrual as of 4/14/2009).

II. Determine overall survival of patients treated with this regimen. III. Determine the
toxicity of this regimen in these patients. IV. Determine radiographic response rate in
patients treated with this regimen. V. Determine progression-free survival of patients
treated with this regimen. VI. Explore molecular correlates of clinical outcome in patients
treated with this regimen.

VII. Explore pharmacokinetic correlates of dosing, toxicity, and efficacy.

OUTLINE: This a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed periodically.

Inclusion Criteria:

- Histologically confirmed glioblastoma multiforme or gliosarcoma

- Pre-therapy tumor tissue available

- Meets 1 of the following criteria:

- Patients accrued to stage 1 (closed to accrual as of 4/14/2009) or stage 1B
(opened to accrual as of 4/14/2009) must have tumors overexpressing at least 2
known dasatinib targets (i.e., SRC, KIT, PDGFR, or EPHA2)

- Patients accrued to stage 2 (closed as of 4/14/2009) do not require
overexpression of SRC, KIT, PDGFR, or EPHA2

- Prior treatment with radiotherapy and temozolomide required

- Radiographic evidence of tumor progression by MRI or CT scan

- Must be on stable or decreasing doses of corticosteroids for at least 5 days
before baseline MRI or CT scan

- Measurable disease is not required in patients who recently underwent resection
provided the following conditions are met as applicable:

- Progression of disease necessitated surgery

- Polifeprosan 20 with carmustine implants (Gliadel wafers®) were not placed
during the most recent surgery

- Neither convection-enhanced delivery nor catheters for infusion of chemotherapy
were used during the most recent surgery

- Radioactive seeds were not placed during the most recent surgery

- The histology of the most recent surgery documented
recurrent/persistent/progressive malignant glioma

- Karnofsky performance status 60-100%

- Absolute neutrophil count ≥ 1,000 cells/mm³

- Platelet count ≥ 75,000 cells/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

- WBC ≥ 3,000 cells/mm³

- Absolute lymphocyte count ≥ 500 cells/mm³

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Creatinine ≤ 3 times ULN OR creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior invasive malignancy except for nonmelanomatous skin cancer unless
disease-free for a minimum of 3 years

- No severe active comorbidity, defined as any of the following:

- Clinically significant cardiovascular disease, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization
within the past 6 months

- Transmural myocardial infarction or ventricular tachyarrhythmia within the
past 6 months

- Prolonged QTc > 480 msec (by Fridericia's correction)

- Ejection fraction less than institutional normal

- Major conduction abnormality (unless a cardiac pacemaker is present)

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization

- No known AIDS

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to dasatinib

- No condition that impairs the ability to swallow or retain tablets, such as the

- Gastrointestinal tract disease resulting in an inability to take oral medication
or a requirement for IV alimentation

- Prior surgical procedures affecting absorption

- Active peptic ulcer disease

- No other concurrent anticancer agents or therapies

- Prior surgery for recurrent/progressive disease allowed

- Recovered from prior surgery

- More than 4 weeks since prior radiotherapy and recovered

- More than 2 weeks since prior temozolomide and recovered

- More than 2 weeks since prior and no concurrent enzyme-inducing antiepileptic drugs

- No prior therapy except radiotherapy and temozolomide

- No prior stereotactic radiosurgery or brachytherapy

- At least 7 days since prior and no concurrent potent inhibitors of CYP3A4

- At least 7 days since prior and no concurrent agents with proarrhythmic potential

- At least 7 days since prior and no concurrent antithrombotic and/or antiplatelet
agents (e.g., warfarin, heparin, low molecular weight heparin, acetylsalicylic acid,
clopidogrel, ticlopidine, or Aggrenox)

- No locally acting antacids (Maalox, Mylanta) within 2 hours before or after study

- No concurrent systemic antacids, including H2 receptor antagonist or proton pump

- No concurrent ibuprofen or NSAIDs

- No concurrent large quantities of grapefruit or its juice

- No concurrent potent inducers of CYP3A4

- No other concurrent investigational agents

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Andrew Lassman

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Radiology Imaging Network


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Glioblastoma
  • Gliosarcoma



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