A Safety Study Utilizing Yondelis and Doxorubicin in Patients With Soft Tissue Sarcoma

This study has been completed.

First Received: January 31, 2005 Last Updated: August 14, 2006 History of Changes

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:	NCT00102609

Purpose

The purpose of the study is to determine the dose of Yondelis and Doxorubicin out of three possible dose groups. A Granulocyte-Colony Stimulation Factor known as filgrastim will be used to help control low white blood cell counts.

Condition	Intervention	Phase
Soft Tissue Sarcoma	Drug: Yondelis and doxorubicin	Phase I

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Ecteinascidin 743

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study to Determine the Dose of the Combination of Yondelis™ and Doxorubicin for Which Neutropenia is Manageable With the Support of Granulocyte-Colony Stimulation Factor in Subjects With Recurrent or Persistent Soft Tissue Sarcoma

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

Primary Outcome Measures:

Safety study of the combination therapy. AEs assessed.

Estimated Enrollment:	58
Study Start Date:	April 2005

Eligibility

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

Criteria

Inclusion Criteria:

Have a diagnosis of soft tissue sarcoma, recurrent or persistent
Signed informed consent obtained for all subjects prior to performing any study-related procedures
Are greater than 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102609

Locations

United States, Georgia

Atlanta, Georgia, United States, 30322
United States, Idaho

Coeur d' Alene, Idaho, United States, 83814
United States, New York

New York City, New York, United States, 10016
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PharmaMar

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial

Johnson & Johnson Pharmaceutical Research and Development, LLC

More Information

No publications provided

Study ID Numbers:	ET743-SAR-1001
Study First Received:	January 31, 2005
Last Updated:	August 14, 2006
ClinicalTrials.gov Identifier:	NCT00102609 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ecteinascidin 743
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Neutropenia
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor

Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents
Doxorubicin
Recurrence

Additional relevant MeSH terms:

Ecteinascidin 743
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Doxorubicin
Pharmacologic Actions

Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on May 07, 2009