Clinical trial · Interventional
Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
A Two-Part, Randomized Phase III, 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 Platinum-Resistant Epithelial Ovarian Cancer And Low HER3 mRNA Expression
NCT01684878CI-TRIAL-00027754completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine (Chemotherapy) | Drug | Gemcitabine | ALIAS |
| Paclitaxel (Chemotherapy) | Drug | Paclitaxel | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Topotecan (Chemotherapy) | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1: Pertuzumab + Topotecan
- description
- Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
- interventionNames
- Drug: Paclitaxel (Chemotherapy)
- Drug: Pertuzumab
- Drug: Topotecan (Chemotherapy)
- type
- EXPERIMENTAL
- label
- Part 1: Pertuzumab + Paclitaxel
- description
- Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
- interventionNames
- Drug: Paclitaxel (Chemotherapy)
- Drug: Pertuzumab
- Drug: Placebo
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLorusso D, Hilpert F, Gonzalez Martin A, Rau J, Ottevanger P, Greimel E, Luck HJ, Selle F, Colombo N, Kroep JR, Mirza MR, Berger R, Pardo B, Grischke EM, Berton-Rigaud D, Martinez-Garcia J, Vergote I, Redondo A, Cardona A, Bastiere-Truchot L, du Bois A, Kurzeder C; PENELOPE trial investigators. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2019 Sep;29(7):1141-1147. doi: 10.1136/ijgc-2019-000370. Epub 2019 Aug 15. PMID 31420414