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Phase I/Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined With Bevacizumab in Recurrent Glioblastoma

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase I/Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined With Bevacizumab in Recurrent Glioblastoma



- Determine the maximum-tolerated dose of dasatinib in combination with bevacizumab in
patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.
(Phase I*)

- Assess the safety and adverse events of this regimen in these patients. (Phase I*)

- Estimate and compare the efficacy of these regimens in these patients as measured by
progression-free survival at six months. (Phase II)


- Describe any preliminary evidence of antitumor activity. (Phase I*)

- Describe the overall toxicity associated with this regimen in these patients. (Phase

- Estimate and compare the efficacy of these regimens in these patients as measured by
overall survival (Phase II)

- Assess the impact of these regimens on the patient's quality of life using FACT-Br (no
longer assessed as of 5/18/2009) (newly added as of 2/2/2010). (Phase II)

- Assess the time to disease progression. (Phase II)

- Assess the safety and toxicity of these regimens in this patient population. (Phase II)

- Determine the relationship between tumor biomarkers and clinical outcome of patients
treated with these regimens. (Phase II) (exploratory)

- Assess the utility of dynamic contrast-enhanced MRI as a predictor of response to these
regimens. (Phase II) (exploratory)

- To assess the utility of MRI diffusion-weighted images (DWI), and specifically the
apparent diffusion coefficient (ADC), as a predictor of response and survival in
patients treated with bevacizumab/dasatinib combination treatment. (Phase II)

- Bank leftover tissue for future NCCTG studies. (Phase II) (exploratory) NOTE: *Phase I

OUTLINE: This is a multicenter, phase I, dose-escalation study (Phase I completed) of
dasatinib followed by a phase II randomized study. Patients are grouped according to study
(1 vs 2). Patients in the phase II portion are stratified according to age (> 70 years of
age vs ≤ 70 years of age), and ECOG performance status (0 vs 1 or 2).

Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive
oral dasatinib once or twice daily on days 1-14 until the maximum-tolerated dose (MTD) is
determined. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity. (Phase I completed)

Phase II (patients are randomized to 1 of 2 treatment arms):

- Arm I: Patients receive bevacizumab as in phase I and dasatinib at the MTD as
determined in phase I. Courses repeat every 14 days in the absence of disease
progression or unacceptable toxicity.

- Arm II: Patients receive bevacizumab as in phase I and oral placebo once or twice daily
on days 1-14. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.

Quality of life is assessed by FACT-Br questionnaire at baseline and prior to every other
course (no longer assessed as of 5/18/2009)(newly added as of 2/2/2010). Tissue samples are
collected at baseline for biomarker studies and assessed by IHC, RT-PCR, and FISH. Patients
undergo dynamic contrast-enhanced MRI at baseline, day 3 of course 1, and day 1 of course 2.

After completion of study therapy, patients are followed up periodically for up to 3 years.

Inclusion Criteria


- Histologically confirmed diagnosis of 1 of the following:

- Grade 3 or 4 glioma, including astrocytoma, oligodendroglioma, and mixed gliomas
(Phase I)

- Glioblastoma* multiforme (grade 4 astrocytoma) (Phase II) NOTE: *Variant
gliosarcomas are allowed

- Evidence of tumor recurrence or progression by MRI or CT scan following radiotherapy
or most recent antitumor therapy

- Patients who have had surgical treatment at recurrence are eligible if they had
a subtotal resection with measurable or non-measurable residual disease on
postoperative imaging or if there is imaging evidence of disease progression as
compared to the first postoperative scan

- Bidimensionally measurable or evaluable disease by MRI or CT scan

- Patients who have had a gross total resection (GTR) are eligible on the basis of
evaluable disease

- No known pleural or pericardial effusion of any grade


- ECOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 9.0 g/dL

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

- SGOT ≤ 3 times ULN

- Creatinine normal

- Urine protein:creatinine ratio < 1 or urine protein < 1,000 mg on 24-hour urine

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- Able to complete questionnaires with or without assistance

- Willing to return to NCCTG enrolling institution for follow-up

- Willing to provide mandatory tissue samples for research purposes

- QTc interval ≤ 450 msec

- No congenital long QT syndrome

- No uncontrolled hypertension (systolic BP of > 150 mm Hg or diastolic BP > 100 mm Hg
on antihypertensive medications)

- Well-controlled hypertension allowed

- No myocardial infarction or unstable angina within the past 6 months

- No NYHA class II-IV congestive heart failure

- No significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
peripheral arterial thrombosis within the past 6 months

- No history of any clinically significant ventricular arrhythmias (i.e., ventricular
tachycardia, ventricular fibrillation, or Torsades de pointes)

- No stroke or transient ischemic attack within the past 6 months

- No history of hypertensive crisis or hypertensive encephalopathy

- No evidence of any CNS hemorrhage on baseline CT or MRI

- No co-morbid systemic illnesses or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- No immunocompromised patients (other than that related to the use of corticosteroids)

- Known HIV positivity without clinical evidence of an immunocompromised state

- No condition (e.g., gastrointestinal tract disease resulting in an inability to take
oral medication or a requirement for IV alimentation or prior surgical procedures
affecting absorption) that impairs ability to swallow pills

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No evidence of bleeding diathesis (greater than normal risk of bleeding) or
coagulopathy (in the absence of therapeutic anticoagulation)

- No active or recent history of hemoptysis (≥ ½ teaspoon of bright red blood per
episode) within the past 30 days

- No uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness or social situations that would limit compliance
with study requirements

- No other active malignancy within the past 3 years except for nonmelanoma skin cancer
or carcinoma in situ of the cervix

- No known hypersensitivity to any of the components of dasatinib or bevacizumab

- No significant traumatic injury within the past 28 days

- No serious nonhealing wounds, active ulcers, or untreated bone fractures

- No hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib

- Patients may not have any clinically significant cardiovascular disease including the

- Myocardial infarction or ventricular tachyarrhythmia within 6 months

- Prolonged QTc ≥ 480 msec (Fridericia correction)

- Ejection fraction less than institutional normal

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

- Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of
breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with
or without stress test as needed in addition to electrocardiogram (ECG) to rule
out QTc prolongation

- Patients with underlying cardiopulmonary dysfunction should be excluded
from the study


- See Disease Characteristics

- Any number of prior chemotherapy regimens for recurrent disease allowed (Phase I)

- No more than 4 weeks since prior chemotherapy, small-molecule cell-cycle inhibitors,
or other investigational agents (≥ 6 weeks since nitrosoureas) at the time of

- More than 1 week since prior aspirin or medications that inhibit platelet function

- No more than 2 prior chemotherapy regimens with ≤ 1 regimen for recurrent disease
(Phase II)

- No prior bevacizumab or VEGF-Trap (Aflibercept)

- No prior intratumoral therapy, stereotactic radiosurgery, or interstitial
brachytherapy except for the following:

- Separate lesion on MRI that is not part of the previous treatment field

- Evidence of recurrent disease based on biopsy, MRI spectroscopy, or PET scan

- At least 7 days since prior core biopsy or other minor surgical procedures (placement
of a vascular access device is allowed)

- At least 7 days since prior drugs that have a risk of causing Torsades de Pointes,
including any of the following:

- Quinidine, procainamide, disopyramide

- Amiodarone, sotalol, ibutilide, dofetilide

- Erythromycin, clarithromycin

- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine

- Prochlorperazine

- At least 28 days since prior and no concurrent major surgical procedure or open

- At least 12 weeks since prior radiotherapy

- No concurrent therapeutic anticoagulation with warfarin, except low-dose warfarin for
venous or arterial access devices, provided INR < 1.5

- Therapeutic anticoagulation with low molecular weight heparin allowed

- No other concurrent investigational agent considered as a therapy for the primary

- No concurrent therapy (other than hormonal therapy) for other prior malignancy

- No concurrent H_2 blockers or proton pump inhibitors that cannot be discontinued or
switched to locally acting agents (i.e., famotidine, omeprazole, Maalox, Mylanta, or

- Use of the following enzyme-inducing anticonvulsive (EIAC) medications is prohibited
≤ 7 days prior to registration: carbemazepine (Tegretol®, Tegretol XR®, Carbatrol®),
phenytoin (Dilantin®, Phenytek®), fosphenytoin (Cerebyx®), phenobarbital,
pentobarbital, and primidone (Mysoline®)

- The following agents are not known to affect dasatinib metabolism and are acceptable
for use: valproic acid (Depakote®, Depacon®), gabapentin (Neurontin®), lomotrigine
(Lamictal®), topiramate (Topamax®), tiagabine (Gabitril®), zonisamid (Zonegram®),
levetriacetam (Keppra®), clonazepam (Klonipin®), and clonozam (Frisium®)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Time to treatment-related toxicity (Phase I)

Safety Issue:


Principal Investigator

Evanthia Galanis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic



Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult giant cell glioblastoma
  • adult glioblastoma
  • adult gliosarcoma
  • adult mixed glioma
  • recurrent adult brain tumor
  • adult anaplastic oligodendroglioma
  • adult oligodendroglioma
  • adult anaplastic astrocytoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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