Study of AMG 479 as Second Line Therapy in Patients With Recurrent Platinum-sensitive Ovarian Cancer
This study has been completed.
Information provided by (Responsible Party):
Cancer International Research Group
First received: July 18, 2008
Last updated: October 30, 2013
Last verified: October 2013
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.
Biological: AMG 479
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multicenter Open Label Phase II Study of the Efficacy and Safety of AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) as Second Line Therapy in Patients With Recurrent Platinum Sensitive Ovarian Cancer
Primary Outcome Measures:
- Overall response rate is defined as the percentage of patients in the group who achieve a complete or partial response according to RECIST criteria and/or GCIG CA 125 response criteria. [ Time Frame: One year after registration of the last patient - approximately 24 months after the first patient is registered ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time To Progression (TTP) is defined as the interval from the date of registration to the date of disease progression [ Time Frame: One year after registration of the last patient - approximately 24 months after the first patient is registered ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Experimental: AMG 479
AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
Biological: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719212
|Los Angeles, California, United States, 90095-1678 |
|Rochester, Minnesota, United States, 55905 |
Cancer International Research Group
||Gottfried E Konecny, MD
||University of California, Los Angeles
No publications provided
||Cancer International Research Group
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 18, 2008
||October 30, 2013
||United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 15, 2014
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases