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

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00060944

Purpose

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

Condition	Intervention	Phase
Liposarcoma Leiomyosarcoma	Drug: Yondelis	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Ecteinascidin 743

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	270
Study Start Date:	April 2003
Estimated Study Completion Date:	February 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Yondelis 0.58 mg/m2 via 3 hr infusion on Days 1, 8, and 15 of each 28-Day treatment	Drug: Yondelis 0.58 mg/m2 via 3 hr infusion on Days 1, 8, and 15 of each 28 day treatment
2: Experimental Yondelis 1.5 mg/m2 24-hour infusion Day 1 of every 21-day treatment cycle	Drug: Yondelis 1.5 mg/m2 24 hour infusion Day 1 of every 21-day treatment cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Johnson and Johnson Pharmaceutical Research and Development ( Eliel Baayever, Sr Director, Clinical Research )
Study ID Numbers:	ET743-STS-201, ET743-STS-201
Study First Received:	May 16, 2003
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00060944 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Liposarcoma
Leiomyosarcoma
Advanced
Metastatic

Study placed in the following topic categories:

Ecteinascidin 743
Neoplasms, Connective and Soft Tissue
Ifosfamide
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Liposarcoma

Leiomyosarcoma
Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents
Isophosphamide mustard

Additional relevant MeSH terms:

Ecteinascidin 743
Neoplasms, Muscle Tissue
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Leiomyosarcoma
Pharmacologic Actions
Neoplasms, Connective and Soft Tissue

Liposarcoma
Neoplasms
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents
Neoplasms, Adipose Tissue

ClinicalTrials.gov processed this record on July 02, 2009