Recurrent Platinum-sensitive ovarian cancer MedDRA version: 9.1 Level: LLT Classification code 10033128 Term: Ovarian cancer
Conditions
Interventions
Product Name: AMG 479
Product Code: AMG 479
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: AMG 479
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
Cancer International research Group
Eligibility
Sex/Gender
All
Inclusion 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 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 as evidenced by: - hemoglobin = 9.0 g/dL - absolute neutrophil count = 1.5 x 109/L - platelet count = 100 x 109/L - Renal function, as follows: - Serum creatinine = 1.5 x the ULN or calculated creatinine clearance = 40 mL/min - AST and ALT = 2.5 x ULN - total bilirubin = 1.5 x ULN unless increase is due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin, - Nondiabetic patients or Type 1 or 2 Diabetic Patients: - Diabetes must be controlled with HgbA1c =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain an estimate of the objective response rate as per RECIST and/or GCIG CA 125 response criteria of AMG 479;Secondary Objective: - To assess clinical benefit response - To assess progression free survival - To assess time to tumor progression - To assess time to tumor marker (CA 125) progression - To evaluate the safety profile of single agent AMG 479 - To assess health-related quality of life - To assess the pharmacokinetics of AMG 479 - To assess patients for the development of anti-AMG 479 antibodies;Primary end point(s): Overal Response rate = percentage of patients in the group who achieve a complete or partial response according to RECIST criteria and/or GCIG CA 125 response criteria. | — |
Countries
France, Germany, Ireland, Spain
Outcome results
None listed