Clinical trial · Interventional
Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer
A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer
NCT01004380CI-TRIAL-00015113completedPhase 1ClinicalTrials.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)
The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.
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 |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Farletuzumab, Carboplatin, and PLD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Farletuzumab
- description
- 2.5 mg/kg once weekly administered i.v. during the Combination treatment period and 7.5 mg/kg Q3W administered i.v. during the Maintenance period
- interventionNames
- Drug: Farletuzumab, Carboplatin, and PLD
Primary outcomes (1)
- measure
- To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.
- timeFrame
- At all study visits.
Secondary outcomes (1)
- measure
- To assess the effect of farletuzumab in combination with carboplatin and PLD on best objective response rate, time to response, and duration of response by RECIST criteria.
- timeFrame
- Every 2 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of epithelial ovarian cancer * Must have measurable disease by CT or MRI scan * Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy * Must have been treated with surgery and be a candidate for repeat carboplatin therapy * Must have a normal cardiac ejection fraction at baseline Exclusion Criteria: * Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs \<6 months from the last platinum therapy * Subjects who have received other therapy to treat their ovarian cancer since last relapse * Known central nervous system tumor involvement * Evidence of other active invasive malignancy * Clinically significant heart disease * Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA * Previous treatment with MORAb 003 (farletuzumab) * Previous treatment with anthracyclines * Clinical contraindications to use PLD
References
Publications (0)
Data not yet available
No reference posted for this study.