A Study of ET743 in Subjects With Advanced Liposarcoma or Leiomyosarcoma - Tabular View

Tracking Information
First Received Date ^ICMJE	May 16, 2003
Last Updated Date	December 27, 2007
Start Date ^ICMJE	April 2003
Estimated Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 27, 2007)	Time from randomization to disease progression or death due to progressive disease [ Time Frame: 6 months after last patient in ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00060944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 27, 2007)	Overall response rate (Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess tumor response) [ Time Frame: 23 months after last patient in ] [ Designated as safety issue: No ] Duration of response [ Time Frame: 23 months after last patient in ] [ Designated as safety issue: No ] Duration of response [ Time Frame: 23 months after last patient ] [ Designated as safety issue: No ] Progression Free Survival and Overall Survival [ Time Frame: 23 months after last patient in ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Study of ET743 in Subjects With Advanced Liposarcoma or Leiomyosarcoma
Official Title ^ICMJE	A Randomized, Multicenter,Open-Label Study of YONDELIS, ET-743 (Ecteinascidin) Administered by Two 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
Brief Summary	This is a study to test the safety and effectiveness of an investigational chemotherapy agent in subjects with advanced liposarcoma or leiomyosarcoma. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the investigator conducting the study
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Parallel Assignment
Condition ^ICMJE	Liposarcoma Leiomyosarcoma
Intervention ^ICMJE	Drug: Yondelis
Study Arms / Comparison Groups	Experimental: Yondelis 0.58 mg/m2 via 3 hr infusion on Days 1, 8, and 15 of each 28-Day treatment Experimental: Yondelis 1.5 mg/m2 24-hour infusion Day 1 of every 21-day treatment cycle
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	270
Estimated Completion Date	February 2008
Estimated Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Male or female subjects 18 years of age or older Advanced or metastatic liposarcoma or leiomyosarcoma Pathology specimen available for centralized review Relapsed or progressive disease Prior treatment with anthracycline and ifosfamide At least one measurable tumor lesion Adequate bone marrow, liver and kidney function ECOG performance status 0 or 1
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00060944
Responsible Party	Eliel Baayever, Sr Director, Clinical Research, Johnson and Johnson Pharmaceutical Research and Development
Study ID Numbers ^ICMJE	ET743-STS-201, ET743-STS-201
Study Sponsor ^ICMJE	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators ^ICMJE	PharmaMar
Investigators ^ICMJE
Information Provided By	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP