Clinical trial • Phase III • Oncology

LETROZOLE for Epithelial ovarian cancer | Fallopian tube cancer | Primary peritoneal carcinoma

Phase III trial of LETROZOLE for Epithelial ovarian cancer | Fallopian tube cancer | Primary peritoneal carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Epithelial ovarian cancer | Fallopian tube cancer | Primary peritoneal carcinoma
Trial Stage
Phase III
Drug Modality
Small molecule | Other

Key dates

Initial CTIS Submission Date
26-07-2024
First CTIS Authorization Date
23-08-2024

Trial design

Randomised, letrozole — active substance letrozole; max daily dose amount 2.5 mg; oral. comparator: the matching placebo to fem345 2.5 mg film-coated tablets (manufactured for trial), oral.-controlled Phase III trial in Germany, Austria.

Randomised
Yes
Comparator
LETROZOLE — active substance LETROZOLE; max daily dose amount 2.5 mg; oral. Comparator: The matching placebo to FEM345 2.5 mg film-coated tablets (manufactured for trial), oral.
Target Sample Size
240

Eligibility

Recruits 240 No vulnerable populations selected. Participants must be adults (Patients must be ≥ 18 years of age). Signed informed consents (ICF-1; ICF-2) are required..

Pregnancy Exclusion
Pregnant or lactating women
Vulnerable Population
No vulnerable populations selected. Participants must be adults (Patients must be ≥ 18 years of age). Signed informed consents (ICF-1; ICF-2) are required.

Inclusion criteria

  • {"criterion_text":"-Patients must be ≥ 18 years of age\n-Negative serum pregnancy test in women of childbearing potential who will get/have gotten a surgical resection or radiation sterilization, prior to the intervention in the therapeutical maintenance setting.\n-Willing and able to attend the visits and to understand all study-related procedures.\n-Primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low or high grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer\n-(Interval-) debulking performed\n-ECOG-Performance Status 0-2\n-Signed informed consents (ICF-1; ICF-2)\n-Paraffin-embedded tissue or paraffin-embedded cell block (from ascites) available\n-Positivity (≥ 1%) for ER expression (only determined by Histopathology Core Facility of MATAO trial)\n-At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)"}

Exclusion criteria

  • {"criterion_text":"-Progressive disease at the end of adjuvant treatment\n-Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)\n-Pregnant or lactating women\n-Any other malignancy within the last 5 years which has impact on the prognosis of the patient\n-< 4 cycles of chemotherapy in total\n-Contraindications to endocrine therapy\n-Inability or unwillingness to swallow tablets\n-Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose mal-absorption"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The primary outcome is Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.","definition_or_measurement_approach":"Time from randomization until date of progression (recurrence) or death by any cause in the absence of progression (Progression-Free Survival, PFS)."}

Secondary endpoints

  • {"endpoint_text":"-Overall Survival (OS), defined for each patient as the time from randomization until the date of death from any cause.","definition_or_measurement_approach":"Time from randomization until date of death from any cause (Overall Survival, OS)."}
  • {"endpoint_text":"-Quality-Adjusted Progression Free Survival (QAPFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression under consideration of the quality of life during this period.","definition_or_measurement_approach":"Time from randomization until progression or death while incorporating quality of life during this period (Quality-Adjusted PFS)."}
  • {"endpoint_text":"-Time until First Subsequent Therapy (TFST), defined for each patient as the time from randomization until the date the patient started the next (second line) subsequent anticancer treatment. Patients not receiving a subsequent anticancer treatment at the time of analysis will be censored at the date they were last known to be alive.","definition_or_measurement_approach":"Time from randomization until start date of next anticancer treatment; censoring at last known alive if no subsequent treatment."}
  • {"endpoint_text":"-Quality adjusted Time Without appearance of any Symptoms and Toxicity (Q-TWiST), related to either the progression of the cancer or side effects of the trial medication from randomization until death.","definition_or_measurement_approach":"Composite measure from randomization until death combining time without symptoms/toxicity and adjusted by quality weights (Q-TWiST)."}

Recruitment

Planned Sample Size
240
Recruitment Window Months
176
Consent Approach
Signed informed consents (ICF-1; ICF-2) are required. Adult participants (≥18 years) provide informed consent. Site-specific subject information and consent form documents are provided (multiple site versions listed).

Geography

Total Number Of Sites
31
Total Number Of Participants
300

Germany

Earliest CTIS Part Ii Submission Date
08-08-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
602
Number Of Sites
23
Number Of Participants
250

Sites

Site Name
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
Department Name
Onkologie Hämatologie
Contact Person Name
Martina Gropp-Meier
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Tanja Fehm
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Frauenheilkunde
Contact Person Name
Ingolf Juhász-Böss
Site Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Michael Eichbaum
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Landesfrauenklinik
Contact Person Name
Markus Fleisch
Site Name
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
Department Name
Frauenklinik
Contact Person Name
Michael Schrauder
Contact Person Email
mschrauder@leopoldina.de
Site Name
Agaplesion Diakonieklinikum Hamburg gGmbH
Department Name
Frauenklinik, Brustzentrum u. Gyn. Tumorzentrum
Contact Person Name
Mustafa Celalettin Ugur
Contact Person Email
celal.ugur@agaplesion.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Gynäkologie & Gynäkologische Onkologie
Contact Person Name
Julia Welz
Contact Person Email
j.welz@kem-med.com
Site Name
Klinikum Wolfsburg
Department Name
ambulanten Onkologiezentrum (amO MVZ)
Contact Person Name
Mignon-Denise Keyver-Paik
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Alexander Burges
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Frauenklinik
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Contact Person Name
Barbara Schmalfeldt
Contact Person Email
b.schmalfeldt@uke.de
Site Name
Frauenaerzte Am Bahnhofsplatz
Department Name
Gynäkologie
Contact Person Name
Christoph Uleer
Contact Person Email
c.uleer@gmx.de
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Alexander Hein
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Poliklinik für Frauenheilkunde und Geburtshilfe, NCT/UCC
Contact Person Name
Pauline Wimberger
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik für Frauengesundheit und Geburtshilfe
Contact Person Name
Annette Hasenburg
Site Name
Klinikum Konstanz GmbH
Department Name
Frauenklinik
Contact Person Name
Andreas Zorr
Contact Person Email
andreas.zorr@glkn.de
Site Name
St. Elisabeth Krankenhaus GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Daniel Rein
Contact Person Email
daniel.rein@hohenlind.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie
Contact Person Name
Radoslav Chekerov
Contact Person Email
radoslav.chekerov@charite.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Ralf Witteler
Contact Person Email
ralf.witteler@ukmuenster.de
Site Name
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
Department Name
Frauenklinik
Contact Person Name
Sara Tato-Varela
Site Name
Romed Klinikum Rosenheim
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Andreas Schnelzer
Contact Person Email
andreas.schnelzer@ro-med.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Fabienne Schochter

Austria

Earliest CTIS Part Ii Submission Date
08-08-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
550
Number Of Sites
8
Number Of Participants
50

Sites

Site Name
Krankenhaus Der Barmherzigen Brueder
Department Name
Abteilung für Gynäkologie
Contact Person Name
Ursula Sevelda
Contact Person Email
ursula.sevelda@bbgraz.at
Site Name
Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH
Department Name
Abt. Gynäkologie und Geburtshilfe
Contact Person Name
Judith Lafleur
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department für Gynäkologie und Geburtshilfe
Contact Person Name
Christian Marth
Contact Person Email
christian.marth@i-med.ac.at
Site Name
Klinik Hietzing
Department Name
Gynäkologisch-geburtshilfliche Abteilungchristian.peters-engl@gesundheitsverbund.at
Contact Person Name
Christian Peters-Engl
Site Name
Medical University Of Vienna
Department Name
Uniklinik für Frauenheilkunde
Contact Person Name
Stephan Polterauer
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Pia Wolfrum-Ristau
Contact Person Email
p.wolfrum-ristau@salk.at
Site Name
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name
Abteilung für Gynäkologie und Geburtshilfe
Contact Person Name
Cornelia Peternell
Contact Person Email
cornelia.peternell@kages.at
Site Name
Medical University Of Graz
Department Name
Klinische Abteilung für Gynäkologie
Contact Person Name
Vassiliki Kolovetsiou-Kreiner

Sponsor

Primary sponsor

Full Name
Swiss GO Trial Group
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Switzerland

Third parties

  • {"country":"Switzerland","full_name":"Universitaetsspital Basel","duties_or_roles":"[{\"id\":979184,\"code\":\"1\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Switzerland","full_name":"Universitaetsspital Basel","duties_or_roles":"[{\"id\":979182,\"code\":\"8\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"[{\"id\":979183,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LETROZOLE
Active Substance
LETROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Already authorised for therapeutic use in other disease areas (see application justification); prodAuthStatus: 2
Maximum Dose
2.5 mg
Investigational Product Name
The matching placebo to FEM345 2.5 mg film-coated tablets
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Manufactured for trial (productChangeDescription: manufactured for trial)

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