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Clinical Trial 18190
Cancer Type: Gynecological Tumor
Interventions:Doxil (doxorubicin liposome); Farletuzumab; Paraplatin (carboplatin); Placebo; Taxol (paclitaxel); carboplatin; doxorubicin liposome; paclitaxel
Study Type: Treatment
Phase of Study: Phase II
- Robert Wenham
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Peglyated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer
This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.
Primary: The primary objective of the study is to demonstrate that farletuzumab has superior efficacy compared to placebo in improving progression-free survival (PFS) as determined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 when added to 1 of 2 standard chemotherapy regimens (carboplatin plus paclitaxel or carboplatin plus PLD) in subjects with platinum-sensitive ovarian cancer in first relapse who have a cancer antigen 125 (CA125) <= 3x the upper limit of normal (ULN) (105 U/mL) at study entry. Secondary: To assess the effect of farletuzumab on overall survival (OS) in this population. To assess the effect of farletuzumab in prolonging second platinum-free interval longer than first platinum-free interval. To assess the effect of farletuzumab on best objective response (OR) rate, time to response (TTR) and duration of response (DR) by RECIST 1.1 criteria. To assess the safety and tolerability of farletuzumab. To assess the pharmacokinetics and exposure-response relationships between farletuzumab and PFS and OS. Exploratory: To explore blood CA125 change pattern during study. To explore biomarkers that may correlate with the efficacy-related endpoints and farletuzumab mechanism of action. To explore expression of CA125 and folate receptor alpha in blood, urine, and tissue to correlate to disease characteristics, exposure, efficacy-related endpoints, farletuzumab mechanism of action, and other biomarkers.