Trial Title:
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma
NCT ID:
NCT06088290
Condition:
Leiomyosarcoma
Conditions: Official terms:
Leiomyosarcoma
Doxorubicin
Conditions: Keywords:
Leiomyosarcoma
Oncology
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lurbinectedin
Description:
Intravenous Infusion
Arm group label:
Phase IIb (& Phase III if selected), Doxorubicin (dose A) + Lurbinectedin (dose B)
Arm group label:
Phase IIb (& Phase III if selected), Doxorubicin (dose C) + Lurbinectedin (dose D)
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Short intravenous push or bolus (according to label)
Arm group label:
Phase IIb & Phase III, Doxorubicin
Arm group label:
Phase IIb (& Phase III if selected), Doxorubicin (dose A) + Lurbinectedin (dose B)
Arm group label:
Phase IIb (& Phase III if selected), Doxorubicin (dose C) + Lurbinectedin (dose D)
Summary:
The primary objective of this phase IIb/III study is to evaluate whether the combination
of lurbinectedin plus doxorubicin given as first line treatment for metastatic
leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review
Committee (IRC) when compared to doxorubicin administered as a single agent.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participant signed and dated written informed consent of the patient obtained before
any study-specific procedure.
2. Age ≥ 18 years.
3. Histologically confirmed diagnosis of metastatic LMS.
4. Radiologically measurable disease according to the RECIST v.1.1.
5. No previous systemic therapy for metastatic disease (i.e., first-line setting) and
no previous anthracyclines. Note: prior chemotherapy (without anthracycline) in the
context of adjuvant or neoadjuvant therapy is allowed.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
7. Adequate hematological, renal, metabolic and hepatic function:
1. Hemoglobin ≥ 9.0 g/dL (patients may have received prior red blood cell [RBC]
transfusion); absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L, and platelet
count
≥ 100 x 109/L.
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x
upper limit of normal (ULN).
3. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin is >
ULN.
4. Albumin ≥ 3.0 g/dL.
5. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's
formula).
6. Left ventricular ejection fraction (LVEF) > 50% assessed by multiple-gated
acquisition scan (MUGA) or echocardiography (ECHO).
8. Wash-out periods:
1. At least three weeks since last prior systemic treatment.
2. At least three weeks since last prior major surgery and one week since last
prior minor surgery.
3. At least two weeks since last prior radiotherapy.
9. Evidence of non-childbearing status for women of childbearing potential (WOCBP).
Exclusion Criteria:
1. Prior treatment with anthracyclines, lurbinectedin or trabectedin.
2. Known low grade leiomyosarcoma (i.e., grade I).
3. Known hypersensitivity to any of the components of the i.v. formulation of
lurbinectedin or doxorubicin.
4. Concomitant diseases/conditions:
1. History of cardiac disease: myocardial infarction or unstable angina within the
year prior to enrollment; or symptomatic or uncontrolled arrhythmia despite
ongoing treatment.
2. Patients with any immunodeficiency, including those known to be infected by
human immunodeficiency virus (HIV).
3. Known chronic active hepatitis or cirrhosis. For Hepatitis B, this includes
positive tests for both Hepatitis B surface antigen and quantitative Hepatitis
B polymerase chain reaction (PCR). For Hepatitis C, this includes positive
tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.
4. Active uncontrolled infection.
5. Any other major illness that, in the Investigator's judgment, will
substantially increase the risk associated with the patient's participation in
this study.
5. Use of strong or moderate inhibitors or strong inducers of CYP3A4 activity within
two weeks prior to the first infusion of lurbinectedin.
6. Prior irradiation if only one target lesion (i.e., measurable) is available, unless
progression of the lesion has been confirmed.
7. Known myopathy.
8. History of another neoplastic disease except for curatively treated basal cell
carcinoma, squamous cell carcinoma of the skin, properly treated carcinoma in situ
of the uterine cervix or breast or superficial bladder tumors (Ta, Tis, or T1) that
have been successfully and curatively treated with no evidence of recurrent or
residual disease within three years prior to randomization. In case of prior
malignancy, theInvestigator should ensure, based on histology or clinical
information, that the metastatic sites are sarcoma and not recurrence of the
original malignancy.
9. Limitation of the patient's ability to comply with the treatment or to follow-up the
protocol.
10. Women who are pregnant or breast feeding and fertile patients (men and women) who
are not using a highly effective method of contraception.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Hospital - Phoenix
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Sarcoma Oncology Center
Address:
City:
Los Angeles
Zip:
90057
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic - Jacksonville
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
Augusta University Georgia Cancer Center
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic - Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine in St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Main Campus
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin
Address:
City:
Graz
Zip:
8036
Country:
Austria
Status:
Recruiting
Facility:
Name:
Medizinische Universität Innsbruck
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Medizinische Universität Wien
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Institut de Cancérologie de l'Ouest - Angers
Address:
City:
Angers cedex 02
Zip:
49055
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice Cedex 2
Zip:
06189
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Centre de Lutte contre le Cancer - Centre Oscar Lambret
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Hospitalier Universitaire Dupuytren 1
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Recruiting
Facility:
Name:
Hôspital de la Timone
Address:
City:
Marseille Cedex 5
Zip:
13005
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Poitiers
Address:
City:
Poitiers
Zip:
86000
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes Cedex
Zip:
35042
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Not yet recruiting
Facility:
Name:
LMU Klinikum - Campus Großhadern
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Helios Klinikum Bad Saarow
Address:
City:
Bad Saarow
Zip:
15526
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitätsmedizin Mannheim
Address:
City:
Manheim
Zip:
68167
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitätsklinikum Münster
Address:
City:
Münster
Zip:
48149
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Tübingen
Address:
City:
Tübingen
Zip:
72016
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centro di Riferimento Oncologico
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Ortopedico Rizzoli
Address:
City:
Bologna
Zip:
40136
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Università Campus Bio-Medico di Roma
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebrón
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Canarias
Address:
City:
La Laguna
Zip:
38320
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañón
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Madrid - CIOCC - HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocío
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Miguel Servet
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Universitätsspital Basel
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Universitaire Vaudois Lausanne
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Not yet recruiting
Facility:
Name:
University Hospital Birmingham NHS Foundation Trust
Address:
City:
Birmingham
Zip:
B15 2GW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Cambridge University Hospitals NHS Foundation Trust
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
The Clatterbridge Cancer Centre NHS Foundation Trust
Address:
City:
Liverpool
Zip:
L7 8YA
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
University College London Hospitals NHS Foundation Trust
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Oxford University Hospitals NHS Foundation Trust
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
September 21, 2023
Completion date:
November 26, 2026
Lead sponsor:
Agency:
PharmaMar
Agency class:
Industry
Source:
PharmaMar
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06088290
