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Multicenter, Open-label Study of YONDELIS (Trabectedin) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma

Phase 3
15 Years
Open (Enrolling)
Advanced or Metastatic Liposarcoma or Leiomyosarcoma

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Trial Information

Multicenter, Open-label Study of YONDELIS (Trabectedin) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma

The study is divided into 2 separate parts (ie, Part 1 and Part 2). Part 1 is a dose finding
part (to find the optimal dose) of trabectedin for Chinese patients, and Part 2 is a
multicenter, randomized (the study medication is assigned by chance), active-controlled (an
active substance that is compared with the study medication to test whether the study
medication has a real effect in clinical study), parallel-group (a study comparing the
response in two or more groups of patients receiving different interventions), open-label
(all people know the identity of the intervention) bridging part comparing the efficacy and
safety of the optimal dose of trabectedin with dacarbazine in the same population as in Part
1. The study (in both Part 1 and Part 2) will consist of a screening phase, a treatment
phase and a follow-up phase. Part 1: Optimal dose (ie, maximum tolerated dose [MTD]) is
determined from the following 3 dose levels: Dose level 1 (1.5 mg/m2), Dose level 2 (1.2
mg/m2), and Dose level 3 (1.0 mg/m2)of trabectedin. Cohorts of 6 patients will be treated at
each dose level. To determine MTD, dose limiting toxicity (DLT; any pre-defined adverse
event that occurs during the first cycle ie, Cycle 1) will be determined. In the first
cohort of 6 patients, (a) if DLT is less than or equal to 1 at a dose level, it is
considered as MTD (b) if DLT is greater than 2, patients will be de-escalated to next dose
level (c) if DLT is equal to 2, 3 more patients will be included at that dose level and if
there will be no DLT in those 3 patients, that dose level is considered as MTD. Part 2: If
the optimal dose found in Part 1 is 1.5 mg/m2, approximately 48 patients will be randomly
assigned to either the trabectedin (approximately 32 patients) or dacarbazine (approximately
16 patients) treatment group in Part 2. If the optimal dose found in Part 1 is below 1.5
mg/m2, 123 patients will be randomly assigned to either the trabectedin (approximately 82
patients) or dacarbazine (approximately 41 patients) treatment group. Safety will be
evaluated by assessing adverse events, clinical laboratory test, multiple gated acquisition
scans, electrocardiograms, vital signs, and physical examination throughout the study up to
30 days after the end of treatment.

Inclusion Criteria:

- Histologically proven, unresectable, locally advanced or metastatic liposarcoma or

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

MTD (1.5, 1.2 or 1.0 mg/m2) is determined by assessing Dose Limiting Toxicity (DLT).

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Xian-Janssen Pharmaceutical Ltd.


China: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

March 2017

Related Keywords:

  • Advanced or Metastatic Liposarcoma or Leiomyosarcoma
  • Advanced or Metastatic liposarcoma or leiomyosarcoma
  • Sarcoma
  • L-sarcoma
  • Liposarcoma
  • Leiomyosarcoma
  • Trabectedin
  • Dacarbazine
  • Yondelis
  • Chinese patients
  • Overall survival
  • Pharmacokinetics
  • Leiomyosarcoma
  • Liposarcoma