A Phase 1/1b, Multicenter, Open-label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617, a Human Monoclonal Antibody Directed Against ANG2, as a Single Agent or Combination Therapy in Adult Subjects with Advanced Solid Tumors
This research study is being done to determine if the investigational drug MEDI367is generally safe, tolerable and effective in people with advanced cancer when given either as a single agent or with other chemotherapy drugs such as: bevacizumab, carboplatin with paclitaxel or carboplatin with gemcitabine. Patients who are eligible are those with advanced solid cancers that are refractory to standard therapy or for those which no standard therapy exists.
Adult patients 18 yrs and older with advanced solid tumors. Must be active, have adequate hematologic, renal, liver function. No anticancer treatment or surgery for 4 weeks and radiation within 2 weeks before treatments starts. Woman cannot be pregnant or breastfeeding, both men and woman must use 2 forms of effective birth control methods and to continue to use effective birth control for 3 months after the last treatment. No untreated brain metastases or spinal cord compression, no other invasive cancer diagnosed within the past 5 years. No unresolved side effects from previous chemotherapy. No history of heart attack or by-pass, within 1 year of starting study drug. No active infections such as: coagulation or bleeding disorders, pulmonary hemorrhage or gross coughing-up of blood within 6 months of starting treatment, no DVT, hepatitis B & C, or HIV. No uncontrolled or intercurrent illness such as; uncontrolled hypertension, unstable angina, peptic ulcer, psychiatric illness, peripheral neuropathy. No allergy or reaction to polysobate20, sodium citrate, citric acid and sucrose or gadolinium.
There are several treatment regimens that will be used to determine the safety, tolerable and effectiveness of MEDI367 in people with advanced cancer. The first group of patients will part of the dose-escalation or dose-expansion phase to determine the best dose of MEDI367. The study drug will be given IV once every 21 days. The second group of patients will receive MEDI367 + bevacizumab, IV either every 21 or 28 days. And the third group of patients will receive MEDI367 in combination with either weekly Paclitaxel, every 28 days, or Carboplatin/Paclitaxel every 21 days or Gemcitabine/Carboplatin ever 21 days. Patients will continue to receive the study drug combination either until side effectives are too toxic or until progressive disease. Patient will have CT scans and MRIâ??s every 2 cycles to determine the response to treatment.
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