A TWO-PART, RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER TRIAL ASSESSING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH STANDARD CHEMOTHERAPY VS. PLACEBO PLUS STANDARD CHEMOTHERAPY IN WOMEN WITH RECURRENT PLATIUM RESISTANT EPITHELIAL OVARIAN CANCER AND LOW HER3 mRNA EXPRESSION
Inclusion Criteria:
- Female patients, >/= 18 years of age
- Histologically or cyctologically confirmed epithelian ovarian cancer that is
platinum-resistant or refractory
- Low HER3 mRNA expression
- Eastern Cooperative Oncology Group (EOCD) performance status 0 to 2
- Left ventricular ejection fraction (LVEF) >/= 55%
- Negative serum pregnancy test in women of childbearing potential
- Women of childbearing potential must agree to use effective contraception as defined
by protocol during and for at least 6 months post study treatment
Exclusion Criteria:
- Non-epithelial tumors
- Ovarian tumors with low malignant potential (i.e. borderline tumors)
- History of another malignancy within the last 5 years, except for tumors with a
negligible risk for metastasis or death, such as adequately controlled basal-cell
carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
or breast
- Previous treatment with more than 2 chemotherapy regimens
- Any prior radiotherapy to the pelvis or abdomen
- Pre-existing peripheral neuropathy >/= CTC grade 2
- Inadequate organ function
- Uncontrolled hypertension or clinically significant cardiovascular disease
- Hepatitis B, hepatitis C or HIV infection
- Current chronic daily treatment with corticosteroids >/= 10 mg per day of
methylprednisolone or equivalent, excluding inhaled steroids History of receiving any
investigational treatment within 28 days prior to first study drug administration,
including prior enrollment into Part 1 of the study
- Concurrent participation in any clinical trial