Status:
COMPLETED
A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PharmaMar
PharmaMar S.A.U.
Conditions:
Soft Tissue Sarcoma
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a G...
Detailed Description
This is a multicenter, open-label (identity of the assigned study treatments will be known to patients and study staff) study to determine the dose of the combination of trabectedin (Yondelis) and Dox...
Eligibility Criteria
Inclusion
- Have a diagnosis of soft tissue sarcoma, recurrent or persistent
- Signed informed consent obtained for all patients before performing any study-related procedures
Exclusion
- Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy)
- Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin
- Less than 4 weeks since radiation therapy
- Known metastases (spread) of cancer to the central nervous system
- Other ongoing serious illness present at the time of enrollment as determined by the Investigator
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00102609
Start Date
April 1 2005
End Date
October 1 2007
Last Update
January 10 2013
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