Overview

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

Status:
Completed
Trial end date:
2016-10-11
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Treatments:
Dacarbazine
Trabectedin
Criteria
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