At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed locally advanced or metastatic liposarcoma or leiomyosarcoma
- ✓Progressive or relapsed disease with prior anthracycline and/or ifosfamide treatment
- ✓At least one measurable tumor lesion
- ✓Adequate bone marrow, liver, and kidney function
- ✕Prior exposure to Yondelis i.v. formulation or ET-743 (ecteinascidin)
- ✕Central nervous system metastases
- ✕Active viral hepatitis or chronic liver disease
- ✕Unstable cardiac condition, congestive heart failure, angina, or myocardial infarction within 1 year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
In Brief
A Phase 2 clinical trial evaluating Yondelis and Dexamethasone for Liposarcoma and Leiomyosarcoma. Completed, enrolled 271 participants across 39 sites in 8 countries.
Detailed Summary
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.
Study Details
Timeline
Interventions
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.