Clinical trial · Interventional
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer
NCT02004093CI-TRIAL-00016230completedPhase 2Results 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 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.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pertuzumab | Drug | Pertuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy + Pertuzumab
- interventionNames
- Drug: pertuzumab
- Drug: paclitaxel
- Drug: gemcitabine
- Drug: carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- interventionNames
- Drug: paclitaxel
- Drug: gemcitabine
- Drug: carboplatin
Primary outcomes (3)
- measure
- Percentage of Participants With Disease Progression or Death
- timeFrame
- Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.