Phase 2
Completed N=149
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
Source: ClinicalTrials.gov NCT02004093 ↗Enrolled (actual)
149
Serious AEs
21.5%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants With Disease Progression or Death — 87.8; 80.0 percentage of participants
Summary
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression or Death |
87.8; 80.0 | — |
| PRIMARY Progression-Free Survival |
34.1; 40.0 | 0.3967 |
| PRIMARY Kaplan-Meier Probability of No Disease or Progression at 1 Year |
24; 21 | — |
| SECONDARY Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements |
74.3; 68.0 | 0.3943 |
| SECONDARY Duration of Response |
28.7; 37.0 | 0.3655 |
| SECONDARY Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year |
18; 18 | — |
| SECONDARY Percentage of Participants With Disease Progression |
83.8; 76.0 | — |
| SECONDARY Time to Progressive Disease |
34.3; 37.3 | 0.8129 |
| SECONDARY Kaplan-Meier Probability of Being Progression Free at 1 Year |
24; 19 | — |
| SECONDARY Time To Response |
6.0; 6.3 | 0.5726 |
| SECONDARY Percentage of Participants Who Died |
45.9; 41.3 | — |
| SECONDARY Overall Survival |
28.2; NA | 0.9261 |
| SECONDARY Kaplan-Meier Probability of Being Alive at 1 Year |
88; 85 | — |
Eligibility Criteria
Inclusion Criteria
- histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
- only 1 previous regimen, which must be platinum-based;
- platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.
Exclusion Criteria
- previous radiotherapy;
- previous treatment with an anti-cancer vaccine or any targeted therapy;
- major surgery or traumatic injury within 4 weeks of study;
- history or evidence of central nervous system metastases.
Data sourced from ClinicalTrials.gov (NCT02004093). 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. Informational only — not medical advice.