Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer

Official Title

Phase II Randomized Double Blind Placebo Controlled Trial of Combination of Pimasertib With SAR245409 or of Pimasertib With SAR245409 Placebo in Subjects With Previously Treated Unresectable Low Grade Ovarian Cancer

Summary:

This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumours.

Trial Description

Primary Outcome:

• Objective Tumour Response

• Progression-Free Survival
• Percentage of Participants With Disease Control
• Overall Survival
• Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
• Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28)
• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death
• Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409
• Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409
• Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumour Tissue and Blood

View this trial on ClinicalTrials.gov