A TRIAL TO ASSESS THE SAFETY AND EFFICACY OF METRONOMIC CYCLOPHOSPHAMIDE, METFORMIN AND OLAPARIB IN ENDOMETRIAL CANCER PATIENTS

Phase 1

• Conditions: -Patients with histologically and/or cytologically documented endometrial carcinoma (type I or type II), recurrent after platinum-based chemotherapy; MedDRA version: 19.0Level: PTClassification code 10014736Term: Endometrial cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004364-11-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

-Woman older than 18 years and younger than 81 year old
-Patients with histologically and/or cytologically documented endometrial carcinoma (type I or type II), recurrent after platinum-based chemotherapy.
-Patients with Eastern Cooperative Oncology Group (ECOG) performance status = 2
-Archival tumor tissue available, or tumor lesion biopsy feasible
-There is no limitation to prior number of therapies
-Patients who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

-Illness, incompatible with metformin treatment, in particular those associated with a risk of hypoperfusion or hypoxia (not limited to): acute or chronic renal failure (creatinine clearance < 60 ml/min); lactic acidocetosis; septic shock; congestive heart failure; respiratory distress; liver failure; chronic alcoholism; uncontrolled seizures; age > 80 years; allergy/hypersensitivity to metformin.
-Previous treatment with cyclophosphamide; or allergy/hypersensitivity to cyclophosphamide.
-Any previous treatment with a PARP inhibitor, including olaparib.
-Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for = 5 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified