A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis®) in Patients with Localized Myxoid / Round Cell Liposarcoma

Phase 1

Conditions: ocalized myxoid / round cell liposarcoma previously untreated with chemotherapy or radiation
MedDRA version: 9.1Level: LLTClassification code 10024630Term: Liposarcoma non-metastatic

Registration Number: EUCTR2007-000035-25-FR

Lead Sponsor: Pharma Mar, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 22

Inclusion Criteria

• Patient´s written informed consent before any study-specific procedure

• Adult patients (= 18 years)

• Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of
pathology specimens for central review and pharmacogenomic studies

• Clinical evidence of localized, non-metastatic tumor, including locally recurring
disease after initial surgery

• Measurable disease (by RECIST)

• No prior chemotherapy or radiation (except for adjuvant post-operative
radiotherapy)

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
(appendix 1)

• Hematologic variables:
o Hemoglobin = 9 g/dL
o Absolute neutrophil count (ANC) = 1,500/µL, and
o Platelet count = 100,000/µL

• Serum creatinine < 1.5 mg/dL or creatinine clearance > 30 mL/min

• Creatinine phosphokinase (CPK) < 2.5 ULN

• Hepatic function variables:
o Total bilirubin < ULN
o Total alkaline phosphatase < 2.5 ULN, or if > 2.5 ULN consider alkaline
phosphatase liver fraction or GGT or 5’ nucleotidase must be < ULN
o AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine
transaminase [SGPT]) must be <2.5 x ULN

• Albumin > 25 g/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Known hypersensitivity to any of the components of the trabectedin i.v.
formulation or dexamethasone

• Pregnant or lactating women or any patient of childbearing potential who are not
employing adequate contraception

• History of another neoplastic disease (except basal cell carcinoma or cervical
carcinoma in situ adequately treated) unless in remission for 5 years or longer

• Known distant metastases

• Other serious illnesses such as congestive heart failure or angina pectoris,
myocardial infarction within 1 year before enrollment, uncontrolled arterial
hypertension or arrhythmias

• Psychiatric disorder that prevents compliance with protocol

• Active viral hepatitis or chronic liver disease

• Active infection

• Any other unstable medical condition

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine the pathological complete response (pCR) rate with trabectedin in <br> patients with localized myxoid / round cell liposarcoma (MRCL). ;Secondary Objective: - Evaluate the objective response rate by RECIST and contrast such response with <br> changes in radiological density and tumor pathology.<br><br>- Describe the incidence and severity of adverse events in this patient population.<br><br>- Exploratory, hypothesis-generating pharmacogenomic analyses to correlate <br> molecular parameters in patient samples with clinical outcomes (pCR).;Primary end point(s): Pathological Complete Response (pCR) rate

Secondary Outcome Measures

Name	Time	Method

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