Overview

Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

Status:
Completed
Trial end date:
2016-04-28
Target enrollment:
0
Participant gender:
Female
Summary
This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel
Pertuzumab
Topotecan
Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed epithelial ovarian, primary peritoneal,
and/or fallopian tube cancer that is platinum-resistant or refractory

- Low Human epidermal growth factor receptor (HER) 3 messenger ribonucleic acid (mRNA)
expression

- At least one measurable and/or non-measurable lesion according to Response Evaluation
Criteria in Solid Tumors (RECIST) version (V) 1.1

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent
(%)

- 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 (borderline tumors)

- History of other malignancy of prognostic relevance within the last 5 years, except
for carcinoma in situ of the cervix or basal cell carcinoma, or 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
carcinoma in situ of the breast

- Previous treatment with more than 2 chemotherapy regimens

- Any prior radiotherapy to the pelvis or abdomen

- History or evidence on physical/neurological examination of central nervous system
disease unrelated to cancer (uncontrolled seizures), unless adequately treated with
standard medical therapy

- Pre-existing peripheral neuropathy >/= common toxicity criteria (CTC) grade 2
(applicable for paclitaxel cohort only)

- Inadequate organ function

- Uncontrolled hypertension or clinically significant cardiovascular disease

- Current known infection with human immunodeficiency virus (HIV) or active infection
with hepatitis B virus (HBV), or hepatitis C virus (HCV)

- 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

- For Part 2 of the trial: prior enrollment into Part 1 of the trial

- Concurrent participation in any therapeutic clinical trial