Clinical trial • Phase III • Oncology

sacituzumab tirumotecan for Endometrial cancer

Phase III trial of sacituzumab tirumotecan for Endometrial cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Endometrial cancer
Trial Stage
Phase III
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
20-10-2023
First CTIS Authorization Date
26-02-2024

Trial design

Randomised, open-label, treatment of physician's choice (tpc) including comparator options listed in protocol: paclitaxel albumin-bound (intravenous infusion; max daily dose 100 mg/m2), paclitaxel (intravenous infusion; max daily dose 80 mg/m2), doxorubicin (intravenous infusion; max daily dose 60 mg/m2).-controlled Phase III trial in Netherlands, Denmark, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of Physician's Choice (TPC) including comparator options listed in protocol: PACLITAXEL ALBUMIN-BOUND (intravenous infusion; max daily dose 100 mg/m2), PACLITAXEL (intravenous infusion; max daily dose 80 mg/m2), DOXORUBICIN (intravenous infusion; max daily dose 60 mg/m2).
Target Sample Size
332

Eligibility

Recruits 332 adults.

Inclusion criteria

  • {"criterion_text":"- Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.\n- Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by BICR.\n- Has received prior platinum-based chemotherapy and anti- programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination."}

Exclusion criteria

  • {"criterion_text":"- Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.\n- Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)\n- Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization\n- Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer\n- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.\n- Has had a recurrence of endometrial carcinoma or carcinosarcoma more than >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. This includes:1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval\n- Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma.\n- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n- Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting\n- Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival (OS) - time to death from any cause"}

Secondary endpoints

  • {"endpoint_text":"- Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants experiencing ≥1 AE (safety reporting)"}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who permanently discontinue study intervention because of an AE"}
  • {"endpoint_text":"- Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30]","definition_or_measurement_approach":"Change from baseline in global health status / QoL score measured by EORTC QLQ-C30"}

Recruitment

Planned Sample Size
332
Recruitment Window Months
48
Consent Approach
Informed consent is obtained using country-specific informed consent forms (L1_ICF_Main consent documents listed per country). Consent documents and addenda are provided per participating country in local languages and local versions; consent is obtained from the adult participant. No assent process for minors is described in the provided records.

Geography

Total Number Of Sites
72
Total Number Of Participants
378

Netherlands

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
77
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Stichting Radboud universitair medisch centrum
Department Name
Medical Oncology
Contact Person Name
Nelleke Ottevanger
Site Name
Academisch Ziekenhuis Leiden
Department Name
Medical Oncology
Contact Person Name
Judith Kroep
Contact Person Email
j.r.kroep@lumc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Medical Oncology
Contact Person Name
Jacqueline Tromp
Contact Person Email
j.m.tromp@amsterdamumc.nl

Denmark

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
28-02-2024
Processing Time Days
5
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Region Midtjylland
Department Name
Oncology
Contact Person Name
Kristina Bak Kristoffersen
Contact Person Email
krikrist@rm.dk
Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Hanne From Mathiesen
Site Name
Herlev Hospital
Department Name
Oncology
Contact Person Name
Nicoline Raaschou-Jensen

Austria

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
28-02-2024
Processing Time Days
22
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Gynaecology and Obstetrics
Contact Person Name
Christian Marth
Site Name
Medical University of Vienna
Department Name
Department of Obstetrics and Gynaecology
Contact Person Name
Stephan Polterauer

Sweden

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
27-02-2024
Processing Time Days
22
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO hematologi, onkologi och strålningsfysik
Contact Person Name
Anjila Koul
Contact Person Email
anjila.koul@skane.se
Site Name
Karolinska University Hospital
Department Name
Tema Cancer, Bäckencancer
Contact Person Name
Magnus Frödin-Bolling

Poland

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
29-02-2024
Processing Time Days
22
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Contact Person Name
Mariusz Bidziński
Contact Person Email
katarzyna.derda@pib-nio.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oncology
Contact Person Name
Bartosz Urbański
Contact Person Email
clinicaltrials@wco.pl
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oncology
Contact Person Name
Lubomir Bodnar
Contact Person Email
bbk@szpital.siedlce.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oncology
Contact Person Name
Beata Maćkowiak-Matejczyk

Ireland

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
01-03-2024
Processing Time Days
18
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Cork University Hospital
Department Name
Oncology
Contact Person Name
Dearbhaile Collins
Contact Person Email
dearbhaile.collins@hse.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Oncology
Contact Person Name
Donal Brennan
Contact Person Email
dbrennan@mater.ie
Site Name
St James's Hospital
Department Name
Cancer Clinical Trials Office
Contact Person Name
Karen Cadoo
Contact Person Email
kcadoo@stjames.ie

Belgium

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
17-04-2024
Processing Time Days
71
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
UZ Leuven
Department Name
Gynaecological Oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncologie Médicale
Contact Person Name
Stéphanie Henry
Site Name
Az Maria Middelares Gent
Department Name
Department of Oncology
Contact Person Name
Christof Vulsteke
Contact Person Email
christof.vulsteke@azmmsj.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Hannelore Denys
Contact Person Email
hannelore.denys@ugent.be

Finland

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
28-02-2024
Processing Time Days
22
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Turku University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Sakari Hietanen
Contact Person Email
sakari.hietanen@varha.fi
Site Name
HUS Helsinki University Hospital
Department Name
Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Contact Person Name
Heini Lassus
Contact Person Email
heini.lassus@hus.fi
Site Name
Tampere University Hospital
Department Name
Outpatient clinic for gynecology
Contact Person Name
Annika Auranen
Contact Person Email
annika.auranen@pirha.fi
Site Name
Kuopio University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Marjo Tuppurainen

Norway

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
26-02-2024
Processing Time Days
19
Number Of Sites
1
Number Of Participants
11

Sites

Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Gynecologic Oncology
Contact Person Name
Vibeke Anett Ingebrigtsen

Czechia

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
26-02-2024
Processing Time Days
19
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Michael J. Halaška, Ph.D.
Contact Person Email
michael.halaska@fnkv.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddeleni radioterapie a onkologie
Contact Person Name
Vojtech Tlusty
Contact Person Email
vojtech.tlusty@nnj.agel.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynekologicko-porodnicka klinika
Contact Person Name
Michal Zikan
Contact Person Email
michal.zikan@bulovka.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Klinika gynekologie, porodnictvi a neonatologie
Contact Person Name
David Cibula
Contact Person Email
david.cibula@vfn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Gynekologicko-porodnicka klinika
Contact Person Name
Vit Weinberger
Contact Person Email
weinberger.vit@fnbrno.cz

Spain

Earliest CTIS Part Ii Submission Date
19-02-2024
Latest Decision Or Authorization Date
11-04-2024
Processing Time Days
52
Number Of Sites
9
Number Of Participants
58

Sites

Site Name
Hospital Universitario La Paz
Department Name
Oncologia
Contact Person Name
Andres Redondo
Contact Person Email
aredondo12@gmail.com
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Oncologia
Contact Person Name
Marta Gil
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncologia
Contact Person Name
Ignacio Romero
Contact Person Email
iromero@fivo.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncologia
Contact Person Name
Luis Manso
Contact Person Email
luismansosanchez@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Oncologia
Contact Person Name
Alejandro Gallego Martinez
Contact Person Email
agallegomar@unav.es
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Medical Oncology
Contact Person Name
Pilar Barretina Ginesta
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncologia
Contact Person Name
Mª Jesus Diaz Rubio
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncologia
Contact Person Name
Jose Alejandro Pérez-Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncologia
Contact Person Name
Carmen Garcia Duran
Contact Person Email
cgarciaduran@vhio.net

France

Earliest CTIS Part Ii Submission Date
15-02-2024
Latest Decision Or Authorization Date
28-02-2024
Processing Time Days
13
Number Of Sites
10
Number Of Participants
90

Sites

Site Name
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Department Name
Oncology
Contact Person Name
Jerome Martin-Babau
Contact Person Email
j.martin@cario-sante.fr
Site Name
Centre D'Oncologie Et De Radiotherapie 37
Department Name
Oncology
Contact Person Name
Pierre Combe
Contact Person Email
p.combe@cort37.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical oncology
Contact Person Name
Laurence Gladieff
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical oncology
Contact Person Name
Stanislas Quesada
Site Name
Centre Oscar Lambret
Department Name
Medical oncology
Contact Person Name
Cyril Abdeddaim
Contact Person Email
c-abdeddaim@o-lambret.fr
Site Name
Institut Bergonie
Department Name
Medical oncology
Contact Person Name
Coriolan Lebreton
Site Name
Centre Leon Berard
Department Name
Medical oncology
Contact Person Name
Isabelle-Laure Ray-Coquard
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncology
Contact Person Name
Thibault De La Motte Rouge
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Medical oncology
Contact Person Name
Frederic Selle
Contact Person Email
fselle@hopital-dcss.org
Site Name
Besancon University Hospital Center
Department Name
Oncology
Contact Person Name
Laura Mansi
Contact Person Email
lmansi@chu-besancon.fr

Greece

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
04-03-2024
Processing Time Days
12
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Metropolitan Hospital
Department Name
2nd Oncology Department
Contact Person Name
Christos Christodoulou
Site Name
Diagnostic & Therapeutic Center of Athens HYGEIA
Department Name
3rd Gynecologic Oncology Department
Contact Person Name
Ioannis Syrios
Contact Person Email
syriosi@yahoo.gr
Site Name
Areteio Hospital
Department Name
B' Surgery Department
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
General Hospital Of Patras Agios Andreas
Department Name
Oncology Unit
Contact Person Name
Athina Christopoulou
Contact Person Email
athinachristo@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date
20-12-2023
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
124
Number Of Sites
12
Number Of Participants
75

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Gynecology and Obstetrics
Contact Person Name
Germana Tognon
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Gynecology Oncology
Contact Person Name
Vanda Salutari
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Oncology and Advanced Technologies
Contact Person Name
Alessandra Bologna
Contact Person Email
Alessandra.Bologna@ausl.re.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Gynecology Oncology
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Gynecological Oncology
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Experimental Uro-Gynecological Oncology
Contact Person Name
Carmela Pisano
Contact Person Email
c.pisano@istitutotumori.na.it
Site Name
Humanitas Research Hospital
Department Name
Medical Oncology and Hematology
Contact Person Name
Armando Santoro
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology
Contact Person Name
Claudio Zamagni
Contact Person Email
zamagniclaudio.sper@aosp.bo.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Medical Oncology and Oncology Prevention
Contact Person Name
Michele Bartoletti
Contact Person Email
michele.bartoletti@cro.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Medical Oncology
Contact Person Name
Emanuele Naglieri
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Gynecology and Obstetrics
Contact Person Name
Annamaria Ferrero
Contact Person Email
annamaria.ferrero@unito.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Gynecological Surgery
Contact Person Name
Francesco Raspagliesi

Germany

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
86
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department für Frauengesundheit
Principal Investigator Name
Tobias Engler
Principal Investigator Email
Tobias.Engler@med.uni-tuebingen.de
Contact Person Name
Tobias Engler
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie
Contact Person Name
Klaus Pietzner
Contact Person Email
klaus.pietzner@charite.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Fabian Trillsch
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Brustzentrum
Contact Person Name
Nikolaus de Gregorio
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Gynäkologie & Gynäkologische Onkologie
Contact Person Name
Florian Heitz
Contact Person Email
f.heitz@kem-med.com
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Universitätsfrauenklinik
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
IQVIA Limited
Responsibilities
Code 4 (sponsor duty code)
Name
Frontage Laboratories Inc.
Responsibilities
Code 4 (sponsor duty code)
Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
Signant Health LLC
Responsibilities
eCOA/eConsent/support (sponsor duty codes listed)

Third parties

  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Reify Health","duties_or_roles":"Patient enrollment support service","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
sacituzumab tirumotecan
Modality
ADC
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus 1
Maximum Dose
4 mg/kg
Investigational Product Name
PACLITAXEL ALBUMIN-BOUND
Active Substance
paclitaxel albumin-bound
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus 2
Maximum Dose
100 mg/m2
Investigational Product Name
PACLITAXEL
Active Substance
paclitaxel
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus 2
Maximum Dose
80 mg/m2
Investigational Product Name
DOXORUBICIN
Active Substance
doxorubicin
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus 2
Maximum Dose
60 mg/m2

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