A Randomized, Multicenter, Open-label Study of YONDELIS ™ (ET-743ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 weeksvs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcomaor Leiomyosarcoma Following Treatment With an Anthracycline andIfosfamide - N/A

Phase 1

• Conditions: Advanced or Metastatic Liposarcoma or Leiomyosarcoma; MedDRA version: 5.0Level: PTClassification code 10039494

• Registration Number: EUCTR2004-002106-29-ES
• Lead Sponsor: Pharma Mar SA Unipersonal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-07
• Study Completion: 2008-05-05
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1.Signed informed consent.
2.Male or female subjects 18 years-of-age or older.
3.Unresectable advanced or metastatic histologically proven liposarcoma or leiomyosarcoma. Subjects with GIST (gastrointestinal stromal tumors) are not eligible.
4.Subjects must have pathology specimens available for centralized review.
5.Subjects must have relapsed or progressive disease prior to enrollment. Subjects must have been treated with an anthracycline and ifosfamide, administered either in combination or as sequential regimens.
6.Progressive, measurable disease as defined in the RECIST guidelines. If the only indicator lesion is in a previously irradiated area, the recurrence must be biopsy proven.
7.Recovery from toxic effects of prior therapies to National Cancer Institute-Common Toxicity Criteria (NCI CTC) Grade 1 or better.
8.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9.Hematologic variables:
-Hemoglobin =9 g/dL
-Absolute neutrophil count (ANC) =1,500/mL
-Platelet count =100,000/mL

10.Serum creatinine £ upper limit of normal (ULN)
11.Hepatic function variables
-Total bilirubin =ULN
-Total alkaline phosphatase = ULN, or if > ULN, then alkaline phosphatase liver fraction or 5’-nucleotidase must be = ULN.
-AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be =2.5xULN
-Albumin =2.5 g/dL

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

1.Pregnant or breast–feeding women, or subjects (male or female) not employing adequate contraception. Acceptable means of birth control include intrauterine device (IUD), oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository.
2.Prior exposure to YONDELIS i.v. formulation, ET-743 (ecteinascidin).
3.More than 2 prior cytotoxic chemotherapy regimens (adjuvant therapy completed more than 18 months before randomization will not be counted as a regimen).
4.Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent.
5.Peripheral neuropathy, Grade 2 or higher.
6.History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated), unless in remission 5 years or more.
7.Known central nervous system (CNS) metastasis.
8.Active viral hepatitis or chronic liver disease.
9.Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias.
10.Active infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: for each treatment arm are as follows:<br>·to estimate the rate and duration of best overall objective responses (CR+PR)<br>·to compare the overall survival (OS), and<br>·to characterize the safety profile <br>·to estimate the pharmacokinetics of YONDELIS i.v. formulation<br>;Primary end point(s): The primary efficacy endpoint of the study will be Time-to-progression (TTP).;Main Objective: To compare time to progression of 2 administration schedules in subjects with liposarcoma and leiomyosarcoma previously treated with anthracycline and ifosfamide.