Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01846871 : Tivozanib for Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01846871      |      Link to official Clinicaltrials.gov listing
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