A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Morphotek
- Enrollment
- 15
- Locations
- 5
- Primary Endpoint
- To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.
Study Overview
Brief Summary
The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.
Detailed Description
Farletuzumab (MORAb-003) is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) in combination with other drugs. Farletuzumab works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and PLD
- is safe, or
- to assess the potential drug-drug interaction, and
- to prolong response to chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Farletuzumab
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
Intervention: Farletuzumab, Carboplatin, and PLD (Drug)
Outcomes
Primary Outcomes
To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.
Time Frame: At all study visits.
Secondary Outcomes
- 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.(Every 2 months)