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Clinical Trials/EUCTR2007-000035-25-DE
EUCTR2007-000035-25-DE
Active, not recruiting
Not Applicable

A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (YONDELIS®) in Patients with Localized Myxoid / Round Cell Liposarcoma

Pharma Mar, S.A.0 sites22 target enrollmentJuly 4, 2008
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Conditionsocally advanced (Stage III) myxoid / round cell liposarcoma previously untreated with chemotherapy or radiationMedDRA version: 9.1Level: LLTClassification code 10024630Term: Liposarcoma non-metastatic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ocally advanced (Stage III) myxoid / round cell liposarcoma previously untreated with chemotherapy or radiation
Sponsor
Pharma Mar, S.A.
Enrollment
22
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 4, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Pharma Mar, S.A.

Eligibility Criteria

Inclusion Criteria

  • •Patient´s written informed consent before any study\-specific procedure
  • •Adult patients (\= 18 years)
  • •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 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 i.v.
  • •formulation or dexamethasone
  • •Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods (one or more of the following):
  • •\- Complete abstinence from intercourse from 2 weeks prior to administration of the
  • •study drug, throughout the study, and for at least 6 months after completion or
  • •premature discontinuation from the study to account for elimination of the
  • •investigational drug; or,
  • •\- Patient or patient’s partner physical sterilization; or,
  • •\- One of the following, for female patients or female partner of male patients:
  • •o Implants of levonorgestrel; or,

Outcomes

Primary Outcomes

Not specified

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