CompletedPhase 3

A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma

China16 participantsStarted 2012-08-07

Plain-language summary

The purpose of this study is to find the optimal dose of trabectedin for Chinese patients with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group is superior to dacarbazine group (Part 2).

Who can participate

Age range15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically proven, unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma * Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen * Measurable disease at baseline in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate recovery from prior therapy; all side effects (except alopecia) have resolved to Grade 1 or less according to the National Cancer Institute * Adequate organ function and hepatic function Exclusion Criteria: * Prior exposure to trabectedin (both Part 1 and Part 2) or dacarbazine (Only Part 2) * Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent * Other malignancy within past 3 years (exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix) * Known central nervous system metastasis * Active or symptomatic viral hepatitis or chronic liver disease

What they're measuring

Part 1: Optimal dose level (Maximum tolerated dose [MTD]) of trabectidin

Timeframe: From the date of dosing until 21days after the date of last patient enrolled

Part 1: Overall survival

Timeframe: From the date of dosing upto 18 months after the last patient enrollment or 30 days after the last dose of study medication has been administered, whichever will be later

Part 2: Overall survival

Timeframe: From the date of randomization until the required number of events has occurred (approximately 32 if 1.5mg/m2, or 82 with below 1.5mg/m2) as assessed approximately for 6 months after the last patient enrollment

Trial details

NCT IDNCT01692678

SponsorXian-Janssen Pharmaceutical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10-11

View on ClinicalTrials.gov More Advanced or Metastatic Liposarcoma or Leiomyosarcoma trials