Phase 3
N=50
Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01684878 ↗Enrolled (actual)
50
Serious AEs
40.4%
Results posted
Nov 2016
Primary outcome: Primary: Part 1: Percentage of Participants With Adverse Events (AEs) — 95.5; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gemcitabine (Chemotherapy) (Drug); Paclitaxel (Chemotherapy) (Drug); Pertuzumab (Drug); Placebo (Drug); Topotecan (Chemotherapy) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Percentage of Participants With Adverse Events (AEs) |
95.5; 100.0 | — |
| PRIMARY Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO) |
4.27; 2.74 | 0.4983 |
| SECONDARY Part 1- Objective Response Rate (ORR) |
14.3; 25.0 | — |
| SECONDARY Part 2- Objective Response Rate (ORR) |
14.8; 8.7 | 0.4102 |
| SECONDARY Part 1: PFS Assessed by the Investigator |
4.07; 4.24 | — |
| SECONDARY Part 2: Progression-free Survival (PFS) Assessed by the Investigator |
4.22; 3.94 | — |
| SECONDARY Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score |
71.1; 74.9; 68.6; 69.4; 59.5; 65.9 | — |
| SECONDARY Part 2: Percentage of Participants With Adverse Events (AEs) |
98.7; 100 | — |
| SECONDARY Part 2: Overall Survival |
10.18; 8.36 | 0.5960 |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01684878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.