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

NCT ID: NCT00719212

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-05-31

Brief 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.

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AMG 479

Intervention Type: BIOLOGICAL

Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

Interventions

AMG 479

Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Translational Research in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gottfried E Konecny, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

St Jude Heritage Healthcare

Fullerton, California, United States

Wilshire Oncology Medical Group Inc

La Verne, California, United States

LAC/USC Medical Center

Los Angeles, California, United States

University of Southern California/ Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

North Valley Hematology/ Oncology Medical Group

Northridge, California, United States

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Central Hematology Oncology Medical Group Inc.

Pasadena, California, United States

University of Colorado

Aurora, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Cancer Center of Kansas

Wichita, Kansas, United States

St Joseph Mercy Health System

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Comprehensive Cancer Centre of Nevada

Henderson, Nevada, United States

Tom Baker Centre

Calgary, , Canada

Juravinski Cancer Center

Hamilton, , Canada

CHUM Hôpital Notre Dama

Montreal, , Canada

Jewish General Hospital

Montreal, , Canada

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, , France

Centre Léon Berard

Lyon, , France

Clinique Hartmann

Neuilly-sur-Seine, , France

Institut Curie

Paris, , France

Institut Gustave Roussy

Villejuif, , France

Charité Campus Benjamin Franklin

Berlin, , Germany

Universitatsklinikum Erlangen

Erlangen, , Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, , Germany

Cork University Hospital

Cork, , Ireland

Mater Misericordiae University Hospital

Dublin, , Ireland

Mater Private Hospital

Dublin, , Ireland

St Jame's Hospital

Dublin, , Ireland

Waterford Regional Hospital

Waterford, , Ireland

Kaplan Medical Center

Rehovot, , Israel

Hospital Universitario de Tenerife

La Laguna (Santa Cruz de Tenerife), , Spain

Hospital U 12 de Octubre

Madrid, , Spain

Hospital Universitario Virgen Macarena de Sevilla

Seville, , Spain

Countries

United States; Canada; France; Germany; Ireland; Israel; Spain

Other Identifiers

TRIO 015

Identifier Type: -

Identifier Source: org_study_id