Étude ENGOT-OV66

Fiche descriptive de l'étude

Étude ovaire

ENGOT-OV66

Titre de l'étude

ENGOT-OV66 : A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer.

Statut

Recrutement terminé / Suivi

Promoteur

ARAVIVE

But

Objectifs principaux

To evaluate the effect of AVB-S6-500 plus Paclitaxel (PAC) (AVB-S6-500 + PAC) versus Placebo and PAC (Placebo + PAC) on progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, in subjects with platinum-resistant recurrent ovarian cancer. 

Objectifs secondaires

• To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on objective response rate (ORR) based on RECIST v1.1 criteria 
• To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on duration of response (DOR) based on RECIST v1.1 criteria
• To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire
• To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on clinical benefit rate (CBR) based on RECIST v1.1 criteria
• To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of AVB-S6-500

Critères principaux d'évaluation

Primary endpoint:

PFS based on investigator-assessed RECIST v1.1 criteria

Secondary endpoints:

• OS
• ORR based on investigator-assessed RECIST v1.1 DOR based on investigator-assessed RECIST v1.1 FACT-O score CBR based on investigator-assessed RECIST v1.1 Multiple PK endpoints, including Cycle 1 Day 15 trough level Exploratory analyses include the following additional assessments: CA-125 per Gynecologic Cancer Intergroup guidelines Expression/activity of AXL pathway biomarkers (eg, AXL, sAXL, and GAS6) Efficacy endpoints in biomarker-defined subgroups will be based on expression/activation of these biomarkers in serum.

Phase

Phase III

Type de patiente

Patients with Platinum-Resistant Recurrent Ovarian Cancer

Nombre de patientes recrutées

400 patientes à l'international dans environ 84 centres

7 patientes en France dans 5 centres