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CASE 4312   |   12-1084
Phase II study of TKI258 (Dovitinib) in patients with recurrent or progressive Glioblastoma who have progressed on anti-angiogenic therapy (including anti-VEGF therapy)

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Phase 2

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  1. Primary Objective:
    • Arm 1: To determine 6 month progression-free survival (PFS6) in anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM) in patients treated with dovitinib
    • Arm 2: To estimate time to progression in this patient population in patients with recurrent or progressive Glioblastoma who have progressed on anti-angiogenic therapy (including anti-VEGF therapy).
  2. Secondary Objectives:
    • To evaluate the side effect profile of dovitinib in this patient population.
    • To evaluate the efficacy of dovitinib as measured by objective response rate (ORR) in this patient population.
    • To estimate time to percentage of patients free from progression at 6 months (PFS-6).
    • To estimate time to progression in anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab)naive patients with recurrent glioblastoma (GBM) in patients treated with dovitinib (Arm 1).
    • To evaluate the overall survival (OS) in this patient population.

Inclusion Criteria
  1. Histologically confirmed glioblastoma, recurrent after standard external-beam fractionated radiotherapy and temozolomide chemotherapy.
  2. Patients who have NOT received any anti-angiogenic therapy (Anti-VEGF, including avastin, cediranib, or other anti-angiogenic therapies like cilengitide) on arm 1. No more than two recurrences are allowed on arm 1.
  3. Patients who have received any anti-angiogenic therapy (Anti-VEGF, including avastin, cediranib, or other anti-angiogenic therapies like cilengitide) on arm 2. No more than two recurrences are allowed on arm 2.
  4. Karnofsky performance status ≥ 60%
  5. Age ≥ 18 years old
  6. Patients must have the following laboratory values:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hemoglobin (Hgb) > 9 g/dL
    • Serum total bilirubin: ≤ 1.5 x ULN
    • ALT and AST ≤ 3.0 x ULN
    • Serum creatinine ≤ 1.5 x ULN
  7. Minimum interval since completion of radiation treatment is 12 weeks
  8. Minimum interval since last drug therapy 2 weeks since last non-cytotoxic therapy 3 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.
  9. Patients must be able to provide written informed consent.
  10. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant. Female patients of child-bearing potential must have a negative pregnancy test.
  11. Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ three years.
  12. Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment.

Exclusion Criteria
  1. Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
  2. Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months.
  3. Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
    • Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
      • History or presence of serious uncontrolled ventricular arrhythmias
      • Clinically significant resting bradycardia
      • LVEF assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (which ever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (which ever is higher)
      • Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), and Transient Ischemic Attack (TIA)
      • Uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication(s)
    • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
    • Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
    • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
    • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
    • Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test ≤ 14 days prior to starting study treatment.
    • Fertile males not willing to use contraception, as stated above
    • Patients who are currently receiving full dose anticoagulation treatment with therapeutic doses of warfarin or anti-platelet therapy (e.g., Plavix® [clopidogrel bisulfate]). Treatment with locally accepted low molecular weight heparin and low dose of acetylsalicyclic acid (i.e., 81mg or 100 mg daily) to prevent cardiovascular events or strokes is allowed
    • Patients unwilling or unable to comply with the protocol
    • Any significant hemorrhage defined as > 1 cm diameter of blood seen on the MRI or CT scan. If > 1 cm of acute blood is detected, the patient will be ineligible for this trial.

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