|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Ifosfamide Ecteinascidin 743 |
| 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 |
| 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 |
Contacts and Locations
More Information
| Responsible Party: | Johnson and Johnson Pharmaceutical Research and Development ( Eliel Baayever, Sr Director, Clinical Research ) |
| Study ID Numbers: | ET743-STS-201, ET743-STS-201 |
| First Received: | May 16, 2003 |
| Last Updated: | December 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00060944 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|