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A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Neoplasms

Thank you

Trial Information

A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

Inclusion Criteria:

- Histologically-confirmed optimally debulked (< 1 cm) FIGO stage III or stage IV
(positive pleural cytology only) ovarian epithelial (including fallopian tube and
primary peritoneal) carcinoma.

- Patients should have undergone surgical debulking, by a surgeon experienced in the
management of ovarian cancer, with the aim of maximal surgical cytoreduction. All
patients must be optimally debulked as defined as having no residual tumor of greater
than 1 cm in the post surgical setting.

- Patients with stage IV disease will be eligible if a positive pleural cytology is the
only extra peritoneal disease.

- Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy
specimens of the primary tumor are required at baseline.

- No prior systemic treatment in the primary disease treatment setting.

- Female > 18 years of age or legal age.

- ECOG performance status ≤ 2.

- Adequate organ and bone marrow function

- Non diabetic patients or Type 1 or 2 Diabetic Patients:

• Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160

- Patient must be willing and able to comply with scheduled visits, and all study

- Informed consent obtained.

- Patients should be able to commence systemic therapy within 6 weeks of cytoreductive

- Life expectancy > 12 weeks.

- Adequate coagulation parameters (within 14 days prior to randomization),
International Normalized Ratio (INR) ≤1.5; Activated Prothrombin Time (APTT) ≤ 1.5 x

Exclusion Criteria:

- Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.

- Borderline tumors (tumors of low malignant potential).

- Planned intraperitoneal cytotoxic chemotherapy.

- Prior systemic anticancer therapy for ovarian cancer.

- Any previous radiotherapy to the abdomen or pelvis.

- Patients with synchronous primary endometrial carcinoma, or a past history of primary
endometrial carcinoma, are excluded unless ALL of the following criteria for
describing the endometrial carcinoma are met: Stage ≤ Ib, no more than superficial
myometrial invasion, no lymphovascular invasion, not poorly differentiated (i.e., not
Grade 3 or papillary serous or clear cell).

- Diagnosis of any second malignancy within the last 5 years, except for adequately
treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix
uteri or curatively treated DCIS/LCIS, or non-melanoma or in situ melanoma skin

- Prior treatment with a humanized monoclonal antibody anticancer therapeutic.

- 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.

- Anticipation of a need for a major surgical procedure or radiation therapy during the

- History of hypersensitivity to recombinant proteins.

- Treatment with radiotherapy, surgery, or an investigational agent within 4 weeks of

- Any of the following within 6 months prior to study enrollment: 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, grade ≥ 2 peripheral neuropathy, 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 pregnant (eg, positive human chorionic
gonadotropin test) or is breast feeding.

- Patient of child-bearing potential is not willing to use adequate contraceptive

- Known active infection, or on antiretroviral therapy for HIV disease.

- Known positive test for chronic hepatitis B or C infection.

- Any other underlying physical or mental condition rendering the patient unable to
understand the nature, scope, and possible consequences of the study.

- Refusal or inability to give informed consent to participate in the study.

- 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 study results, and in the judgment of the investigator would make
the patient inappropriate for entry into this study

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS), which is defined as the time from randomization until date of progression or death will be the primary endpoint of this study

Outcome Time Frame:

96 PFS Events - approximately 34 months after the 1st patient is randomized

Safety Issue:


Principal Investigator

Gottfried E Konecny, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Los Angeles


United States: Food and Drug Administration

Study ID:

TRIO 014



Start Date:

January 2009

Completion Date:

May 2015

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



Mayo Clinic Rochester, Minnesota  55905
Cedars-Sinai Medical Center Los Angeles, California  90048
Florida Hospital Cancer Institute Orlando, Florida  32804
Hope A Women's Cancer Center Asheville, North Carolina  28801
UCLA Los Angeles, California  90095
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
Yale University School Of Medicine New Haven, Connecticut  06520
Providence Saint Joseph Medical Center Burbank, California  91505-4866
University of Toledo Toledo, Ohio  43614
Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157
Central Coast Medical Oncology Corporation Santa Maria, California  93454
Memorial Cancer Institute Pembroke Pines, Florida  33028
Winship Cancer Institute Emory University School of Medicine Atlanta, Georgia  30322
University of Southern California Rochester, Minnesota  55905