Informations générales (source: ClinicalTrials.gov)
Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma (SaLuDo)
Interventional
Phase 2/Phase 3
PharmaMar (Voir sur ClinicalTrials)
septembre 2023
novembre 2026
26 septembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:38 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Axel LE CESNE | 17/05/2024 12:08:55 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice Cedex 2 - Provence Alpes Cote D-Azur - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte contre le Cancer - Centre Oscar Lambret - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Centre Eugène Marquis - 35042 - Rennes Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Poitiers - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Dupuytren 1 - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69008 - Lyon - Rhone-Alpes - France | Contact (sur clinicalTrials) | ||||
| Hôspital de la Timone - 13005 - Marseille Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Angers - 49055 - Angers cedex 02 - Pays De La Loire - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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).
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).
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.