Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

September 23, 2016

Primary Completion Date

November 30, 2018

Study Completion Date

June 30, 2020

Conditions
Recurrent Endometrial Cancer
Interventions
DRUG

Olaparib

"Olaparib tablet dose will be dose-escalated on 4 dose levels , guided by a continual reassessment method (CRM).~One cycle will be 28 days (4 weeks) in duration, except for cycle 1 which will be 6 weeks."

DRUG

metformin

From week 3 metformin will be gradually escalated from 500 mg/day to 1500 mg/day with weekly 500 mg dose escalation levels

DRUG

metronomic cyclophosphamide

from week 2 Metronomic cyclophosphamide will be given continuously on an oral daily basis at 50 mg qd

Trial Locations (6)

14076

Service d'Oncologie Médicale, Centre François Baclesse, Caen

59000

Département de Cancérologie Cervico-Faciale et Thoracique, Centre Oscar Lambret, Lille

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75248

Service d'Oncologie Médicale, Institut Curie, Paris

94800

Comité Gynécologique, Institut Gustave Roussy, Villejuif

06189

Département d'Oncologie Médicale, Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02755844 - Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients | Biotech Hunter | Biotech Hunter