Study of AMG 479 as Second Line Therapy in Patients With Recurrent Platinum-sensitive Ovarian Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms
Intervention: AMG 479
Intervention description: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to obtain an estimate of the objective response rate (ORR) of
      AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian
      tube and primary peritoneal) carcinoma failing frontline chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed ovarian epithelial (including fallopian tube and primary
             peritoneal) carcinoma. Baseline paraffin embedded tissue from the patient's primary
             diagnosis is requested before study enrollment and should be forwarded to the
             designated central laboratory. In patients with measurable disease or sufficient
             ascites, fresh frozen tissue or ascites fluid should be obtained by needle biopsy and
             submitted to the designated central laboratory.

          -  Prior treatment with at most 1 treatment regimen in the primary treatment setting.

          -  Platinum-sensitive disease defined by recurrence or progression of disease > 6 months
             AND < 24 months after completion of prior platinum based chemotherapy.

          -  Female > 18 years of age or legal age.

          -  ECOG performance status ≤ 1.

          -  Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST)
             criteria. Subjects with non-measurable disease with a biochemical recurrence are
             eligible provided the CA 125 is elevated by more than 2 times the upper limits of
             normal, confirmed in two successive samples, drawn at least one week apart.

          -  Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v.3.0
             Grade ≤ 1 and to baseline laboratory values as defined in the inclusion criterion
             immediately below.

          -  Adequate organ and bone marrow function

          -  Nondiabetic patients or Type 1 or 2 Diabetic Patients controlled with HgbA1c < 8% and
             fasting blood glucose level <160 mg/dL

          -  Adequate coagulation parameters (within 21 days prior to registration), International
             Normalized Ratio (INR) ≤1.5; Activated ProThrombin Time (APTT) ≤ 1.5 x ULN.

        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.