NCT01692678

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

August 7, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2016

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

August 6, 2012

Last Update Submit

July 9, 2018

Conditions

Advanced or Metastatic Liposarcoma or Leiomyosarcoma

Keywords

Advanced or Metastatic liposarcoma or leiomyosarcomaSarcomaL-sarcomaLiposarcomaLeiomyosarcomaTrabectedinDacarbazineYondelisChinese patientsOverall survivalPharmacokinetics

Outcome Measures

Primary Outcomes (3)

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

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

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

  • Part 1: Overall survival

    Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.

    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

    Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.

    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

Secondary Outcomes (10)

  • Part 1: Progression free survival (PFS)

    From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment

  • Part 2: Progression free survival (PFS)

    From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment

  • Part 1: Time-to-progression (TTP)

    From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment

  • Part 2: Time-to-progression (TTP)

    From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment

  • Part 1: Objective Response Rate (ORR)

    From date of dosing until the date of best response, as assessed up to 18 months after the last patient enrollment

  • +5 more secondary outcomes

Study Arms (2)

Trabectedin (Part 1 and Part 2)

EXPERIMENTAL

Trabectedin will be administered at a dose of 1.5, 1.2 or 1.0 mg/m2 as a 24-hour intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).

Drug: Trabectedin

Dacarbazine (Part 2)

ACTIVE COMPARATOR

Dacarbazine will be administered at a dose of 1 g/m2 as a longer than 30-minute intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).

Drug: Dacarbazine

Interventions

TrabectedinDRUG

Type=exact number, unit=mg/m2, number=1.5, 1.2 or 1.0, form=solution, route=intravenous infusion. Trabectedin will be administered on Day 1 of each 21-day treatment cycle.

Also known as: YONDELIS
Trabectedin (Part 1 and Part 2)
DacarbazineDRUG

Type=exact number, unit=g/m2, number=1, form=solution, route=intravenous infusion. Dacarbazine will be administered on Day 1 of each 21-day treatment cycle.

Dacarbazine (Part 2)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Beijing, China

Location

Unknown Facility

Shanghai, China

Location

Related Links

MeSH Terms

Conditions

LiposarcomaLeiomyosarcomaSarcoma

Interventions

TrabectedinDacarbazine

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTriazenesOrganic ChemicalsImidazolesAzoles

Study Officials

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

    Xian-Janssen Pharmaceutical Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2012

First Posted

September 25, 2012

Study Start

August 7, 2012

Primary Completion

October 11, 2016

Study Completion

October 11, 2016

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

CN(2)