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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00060944 |
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Date of registration:
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16/05/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
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Scientific title:
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A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 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 |
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Date of first enrolment:
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May 2003 |
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Target sample size:
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271 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00060944 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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Canada
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France
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Germany
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Russian Federation
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Spain
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United States
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
- Have a pathology specimen available for centralized review
- Have progressive or relapsed (reappearance of) disease, received treatment with
anthracycline and/or ifosfamide before enrollment in study, and have at least one
measurable tumor lesion
- Have adequate bone marrow, liver and kidney function
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
- Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
- Cancer that has metastasized (spread) to the central nervous system
- Active viral hepatitis or chronic liver disease
- Unstable cardiac (heart) condition including congestive heart failure or angina
pectoris (heart pain), myocardial infarction (heart attack) within 1 year before
enrollment
- History of another neoplastic (malignant or nonmalignant tumor) disease (except basal
cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5
years or more before enrollment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liposarcoma
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Leiomyosarcoma
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Intervention(s)
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Drug: Yondelis
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Drug: Dexamethasone
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Primary Outcome(s)
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Time to Progression- Independent Review
[Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years]
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Secondary Outcome(s)
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Overall Survival
[Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years]
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Progression-Free Survival - Independent Review
[Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years]
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Percentage of Participants Objective Response - Independent Review
[Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years]
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Duration of Response - Independent Review
[Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years]
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Secondary ID(s)
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ET743-STS-201
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CR004336
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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