Ovarian Carcinoma
ENGOT-ov54/Swiss-GO-2/MATAO
Title in German |
MATAO: MAintenance Therapie/ Erhaltungstherapie mit Aromatasehemmer für Patientinnen mit epithelialem Ovarialkarzinom: eine randomisierte doppelblinde Placebo-kontrollierte multizentrische Phase III Studie. (ENGOT-ov54/Swiss-GO-2/MATAO) |
Title in English |
MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer: a randomized double-blinded placebo-controlled multi-center phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO) including LOGOS (Low Grade Ovarian cancer Sub-study) |
Description |
Femara (letrozole) is a well-studied medicine and has been approved by drug regulators for patients with breast cancer for 15 years. Letrozole belongs to the group of aromatase inhibitors. It blocks the production of the female steroid hormone estrogen, which promotes the growth of estrogen receptor positive cancer cells. By taking one tablet of Letrozole (2.5 mg) daily, the body's own estrogen is reduced by 95%, which can suppress the growth of cancer cells in patients in the event of a relapse. Esterogen receptors can also often be detected on the tumor surface in ovarian cancer. Therefore, letrozole could also be a potentially suitable drug for women with ovarian cancer. The MATAO study is a drug study that examines the effectiveness of the drug letrozole on estrogen receptor-positive ovarian cancer tumor growth and prevention of recurrence. The time between the start of the clinical study and the possible progression of the disease is assessed as the so-called primary endpoint. A total of around 540 participants in Germany, Austria and Switzerland will be included in the study. Around 240 participants are planned for Switzerland alone. 50% of patients receive treatment with letrozole and 50% of patients receive a dummy drug without active ingredient (placebo). A computer program is used to randomly assign patients and neither the participant nor the treatment team knows who will receive the study drug letrozole or placebo. |
Phase |
3 |
Head Clinical Trial |
|
Study Nurse |
|
Back-up |
|
Status |
active since 08.03.2021 |
BASEC Nummer |
2020-00148 |
KOFAM |
SNCTP000004053 |
WHO-Register-Nummer |
NCT04111978 |
Insel-Nummer |
4605 |
AMGEN 20210007
Title in German |
Erste Phase-1-Studie am Menschen zur Untersuchung der Sicherheit, Verträglichkeit und Pharmakokinetik von AMG 794 bei Patienten mit Claudin 6-positivem fortgeschrittenem/metastasiertem nicht-plattenepithelialem nicht-kleinzelligem Lungenkrebs oder epithelialem Eierstockkrebs |
Title in English |
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 794 in Subjects With Claudin 6-positive Advanced/Metastatic Non-squamous Non-small Cell Lung Cancer or Epithelial Ovarian Cancer |
Phase/Biobank/ect. |
1 |
Head Clinical Trial |
|
Study-Nurse |
|
Back-up |
|
Back-up |
|
Status |
temporarily closed for patient recruitment: 04.05.2023 |
BASEC Nummer |
2022-01120 |
KOFAM |
|
EudraCT No. |
|
WHO-Register-Nummer |
|
Insel-Nummer |
5301 |