Clinical Trial Details
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NCT01846871 : Tivozanib for Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- 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
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