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Not Recruiting
Trial ID: NCT01248949
Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617 as a Single-Agent or in Combination Therapy in Adult Subjects With Advanced Solid Tumors
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Professor of Neurology and, by courtesy, of Neurosurgery
Inclusion Criteria:
- Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or
another solid tumor type based on antitumoral activity (dose-expansion phase) that are
not responsive to standard therapy or for which no standard therapy exists
- Patients must be 18 years of age or older
- Karnofsky Performance Status ≥ 70
- Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or < 2
- Adequate organ and marrow function
- Using adequate contraceptive measures, be surgically sterile or post-menopausal
Exclusion Criteria:
- Concurrently enrolled in another clinical study, except for non-interventiona
observational studies, or if in a follow up period from a previous study
- Receipt of any investigational anticancer therapy within 30 days prior to the first
dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days
prior to the first dose of MEDI3617
- Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie1 or
Tie2 including, but not limited to, AMG386, CVX-060, XL880, and XL820
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy
for cancer treatment
- Use of immunosuppressive medication or systemic steroids within 7 days prior to first
dose of MEDI3617
- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or study
results
- Known bleeding diathesis
- Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment
- Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment
drug: MEDI3617
drug: Bevacizumab
drug: Paclitaxel
drug: Carboplatin
Not Recruiting
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