Study of AMG 479 as Second Line Therapy in Patients With Recurrent Platinum-sensitive Ovarian Cancer

Exclusion Criteria

• •More than 1 prior chemotherapy regimen in the treatment of ovarian cancer.
• •Platinum-resistant disease as defined by a recurrence or progression less or equal to six months after completion of the frontline platinum based chemotherapy.
• •Anticipation of a need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial.
• •Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
• •Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
• •Previous exposure to AMG 479.
• •History of hypersensitivity to recombinant proteins.
• •Prior treatment with a humanized monoclonal antibody.
• •Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrolment.
• •Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
• •History of brain metastases, spinal cord compression, or carcinomatous meningitis.
• •Patient of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
• •Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
• •Known active infection, or on antiretroviral therapy for HIV disease.
• •Known positive test for chronic hepatitis B or C infection.
• •Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial.
• •Refusal or inability to give informed consent to participate in the trial.
• •Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial.