Trial · NCT01684878
Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
NCT01684878, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-11-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE). Trials, record NCT01684878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01684878
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
- NCT number
- NCT01684878
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 208 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Ovarian Cancer
- Interventions
- Gemcitabine (Chemotherapy), Paclitaxel (Chemotherapy), Pertuzumab, Placebo, Topotecan (Chemotherapy)
- First posted
- 2012-09-13
- Last updated
- 2017-05-23
- Other registries' IDs
- eudract:2011-005975-17
- Results first posted
- 2016-11-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Adverse Events (AEs) | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) | An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Primary | Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO) | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. |
| Secondary | Part 1- Objective Response Rate (ORR) | Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression) | ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Part 2- Objective Response Rate (ORR) | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Part 1: PFS Assessed by the Investigator | Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression) | PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day. |
| Secondary | Part 2: Progression-free Survival (PFS) Assessed by the Investigator | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. |
| Secondary | Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score | Baseline (assessed at baseline and every 9 weeks from randomization until disease progression) | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life. |
| Secondary | Part 2: Percentage of Participants With Adverse Events (AEs) | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) | An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Secondary | Part 2: Overall Survival | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants With Adverse Events (AEs) | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) | All Treated population included all participants enrolled and treated in Part 1 of the study ('as treated' analysis) and who had received at least 1 dose of pertuzumab or chemotherapy. | percentage of participants | NUMBER |
| PRIMARY | Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO) | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | ITT Population was defined as all randomized participants in the group to which they were randomly assigned ('as randomized' analysis). | months | MEDIAN |
| SECONDARY | Part 1- Objective Response Rate (ORR) | Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression) | All Treated participants with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Part 2- Objective Response Rate (ORR) | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | ITT population with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Part 1: PFS Assessed by the Investigator | Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression) | All Treated population included all participants enrolled and treated in Part 1 of the study ('as treated' analysis) and who had received at least 1 dose of pertuzumab or chemotherapy. | months | MEDIAN |
| SECONDARY | Part 2: Progression-free Survival (PFS) Assessed by the Investigator | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | ITT Population included all randomized participants in the group to which they were randomly assigned ('as randomized' analysis) | months | MEDIAN |
| SECONDARY | Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score | Baseline (assessed at baseline and every 9 weeks from randomization until disease progression) | ITT population included all randomized participants in the group to which they were randomly assigned ('as randomized' analysis). | units on a scale | MEAN |
| SECONDARY | Part 2: Percentage of Participants With Adverse Events (AEs) | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) | Safety population included all participants who had received at least 1 dose of pertuzumab, pertuzumab-placebo, or chemotherapy. | percentage of participants | NUMBER |
| SECONDARY | Part 2: Overall Survival | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) | ITT Population included all randomized participants in the group to which they were randomly assigned ('as randomized' analysis) | months | MEDIAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percentage of Participants With Adverse Events (AEs) | Part 1: Pertuzumab + Topotecan | 95.5 | percentage of participants | ||
| Part 1: Percentage of Participants With Adverse Events (AEs) | Part 1: Pertuzumab + Paclitaxel | 100.0 | percentage of participants | ||
| Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO) | Part 2: Pertuzumab+Chemotherapy | 4.27 | 95% Confidence Interval 3.65 to 6.11 | months | |
| Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO) | Part 2: Placebo+Chemotherapy | 2.74 | 95% Confidence Interval 2.14 to 4.73 | months | |
| Part 1- Objective Response Rate (ORR) | Part 1: Pertuzumab + Topotecan | 14.3 | percentage of participants | ||
| Part 1- Objective Response Rate (ORR) | Part 1: Pertuzumab + Paclitaxel | 25.0 | percentage of participants | ||
| Part 2- Objective Response Rate (ORR) | Part 2: Pertuzumab+Chemotherapy | 14.8 | 95% Confidence Interval 7.0 to 26.2 | percentage of participants | |
| Part 2- Objective Response Rate (ORR) | Part 2: Placebo+Chemotherapy | 8.7 | 95% Confidence Interval 3.3 to 18.0 | percentage of participants | |
| Part 1: PFS Assessed by the Investigator | Part 1: Pertuzumab + Topotecan | 4.07 | 95% Confidence Interval 1.94 to 6.08 | months | |
| Part 1: PFS Assessed by the Investigator | Part 1: Pertuzumab + Paclitaxel | 4.24 | 95% Confidence Interval 3.45 to 6.01 | months |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Safety Run in Phase | STARTED | Part 1: Pertuzumab + Topotecan | 22 | |
| Part 1: Safety Run in Phase | STARTED | Part 1: Pertuzumab + Paclitaxel | 28 | |
| Part 1: Safety Run in Phase | STARTED | Part 2: Pertuzumab+Chemotherapy | 0 | |
| Part 1: Safety Run in Phase | STARTED | Part 2: Placebo+Chemotherapy | 0 | |
| Part 1: Safety Run in Phase | COMPLETED | Part 1: Pertuzumab + Topotecan | 6 | |
| Part 1: Safety Run in Phase | COMPLETED | Part 1: Pertuzumab + Paclitaxel | 5 | |
| Part 1: Safety Run in Phase | COMPLETED | Part 2: Pertuzumab+Chemotherapy | 0 | |
| Part 1: Safety Run in Phase | COMPLETED | Part 2: Placebo+Chemotherapy | 0 | |
| Part 1: Safety Run in Phase | NOT COMPLETED | Part 1: Pertuzumab + Topotecan | 16 | |
| Part 1: Safety Run in Phase | NOT COMPLETED | Part 1: Pertuzumab + Paclitaxel | 23 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events580
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Part 1: Pertuzumab + Topotecan | 14 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | Part 1: Pertuzumab + Paclitaxel | 22 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | Part 2: Pertuzumab+Chemotherapy | 50 | 77 | |
| other | Diarrhoea | Gastrointestinal disorders | Part 2: Placebo+Chemotherapy | 23 | 76 | |
| other | Nausea | Gastrointestinal disorders | Part 1: Pertuzumab + Topotecan | 11 | 22 | |
| other | Nausea | Gastrointestinal disorders | Part 1: Pertuzumab + Paclitaxel | 10 | 28 | |
| other | Nausea | Gastrointestinal disorders | Part 2: Pertuzumab+Chemotherapy | 31 | 77 | |
| other | Nausea | Gastrointestinal disorders | Part 2: Placebo+Chemotherapy | 34 | 76 | |
| other | Vomiting | Gastrointestinal disorders | Part 1: Pertuzumab + Topotecan | 13 | 22 | |
| other | Vomiting | Gastrointestinal disorders | Part 1: Pertuzumab + Paclitaxel | 5 | 28 |
1 to 10 of 580Source ClinicalTrials.gov
See all 580 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Pertuzumab + Topotecan | ||
| Total, all-cause mortality | Part 1: Pertuzumab + Paclitaxel | ||
| Total, all-cause mortality | Part 2: Pertuzumab+Chemotherapy | ||
| Total, all-cause mortality | Part 2: Placebo+Chemotherapy | ||
| Total, other adverse events | Part 1: Pertuzumab + Topotecan | 21 | 22 |
| Total, other adverse events | Part 1: Pertuzumab + Paclitaxel | 27 | 28 |
| Total, other adverse events | Part 2: Pertuzumab+Chemotherapy | 72 | 77 |
| Total, other adverse events | Part 2: Placebo+Chemotherapy | 75 | 76 |
| Total, serious adverse events | Part 1: Pertuzumab + Topotecan | 9 | 22 |
| Total, serious adverse events | Part 1: Pertuzumab + Paclitaxel | 11 | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31420414 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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