Tivozanib for Recurrent Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Intervention: Tivozanib
Intervention MeSH terms: Tivozanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research study is a Phase II clinical trial, which tests the safety and effectiveness of
      an investigational drug to learn whether the drug works in treating a specific cancer.
      "Investigational" means that the study drug tivozanib is still being studied. It also means
      that the FDA has not yet approved tivozanib for your type of cancer.

      Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking
      the blood supply to the tumor, so that the tumor does not receive the nutrients it requires
      to grow.

      In this research study, we are looking to see what effects, good and bad, tivozanib will have
      on you and your disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed glioblastoma that has progressed based on imaging or surgery

          -  Measurable disease

          -  No more than 3 prior chemotherapy regimens

          -  Must have recovered from toxicity of prior therapy. An interval of at least 3 months
             must have elapsed since the completion of the most recent course of radiotherapy; at
             least 3 weeks since last non-nitrosourea containing chemotherapy regimen or
             molecularly targeted agent; at least 6 weeks since the completion of a nitrosourea
             containing chemotherapy regimen

          -  Life expectancy of at least 12 weeks

          -  Able to tolerate MRIs

          -  Willing to use adequate, highly effective contraception measures while on study and
             for at least 45 days after the last dose of study drug

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Major surgical procedure or significant traumatic injury within 28 days of starting
             therapy; or minor surgical procedure within 7 days

          -  Receiving other study agents

          -  Prior therapy with an anti-VEGF agent

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to tivozanib

          -  Receiving any medications or substances that are inhibitors or inducers of CYP450
             enzymes

          -  Significant cardiovascular disease

          -  Non-healing wound, bone fracture or skin ulcer

          -  Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other
             gastrointestinal condition with increased risk of perforation; abdominal fistula,
             gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to
             administration of first dose of study drug

          -  Uncontrolled intercurrent illness

          -  Significant thromboembolic or vascular disorders within 6 months prior to
             administration of first dose of study drug

          -  Significant bleeding disorders within 6 months prior to administration of first dose
             of study drug

          -  Currently active second primary malignancy

          -  HIV positive and on combination antiretroviral therapy

          -  Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that
             severely affects the absorption of study drugs, major resection of the stomach or
             small bowel, or gastric bypass procedure