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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: |
NCT00579501 |
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Date of registration:
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20/12/2007 |
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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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Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
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Scientific title:
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A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00579501 |
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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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France
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Germany
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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:
- Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of
pathology specimens for central review and pharmacogenomic studies
- Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including
locally recurring disease after initial surgery
- Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST])
- No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
Exclusion Criteria:
- Known hypersensitivity to any of the components of the trabectedin intravenous (iv)
formulation or dexamethasone
- Pregnant or lactating women and women of reproductive potential who are not using
effective contraceptive methods
- History of another neoplastic disease (except basal cell carcinoma or cervical
carcinoma in situ adequately treated) unless in remission for 5 years or longer
- Known distant metastases
- Other serious illnesses such as congestive heart failure or angina pectoris,
myocardial infarction within 1 year before enrollment, uncontrolled arterial
hypertension or arrhythmias
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,Myxoid
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Intervention(s)
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Drug: Dexamethasone
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Drug: Trabectedin
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Primary Outcome(s)
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Percentage of Participants With Pathological Complete Response (pCR)
[Time Frame: Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.]
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Secondary Outcome(s)
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Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)
[Time Frame: Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.]
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Secondary ID(s)
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CR014767
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ET-B-028-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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