Status:
COMPLETED
A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycl...
Eligibility Criteria
Inclusion
- adult patients, \>/=18 years of age
- well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery
- willing to undergo tumor biopsies before, during and after treatment
- ECOG performance status 0-1
Exclusion
- previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable
- patients receiving any other agent or therapy to treat their malignancy
- patients requiring anticoagulant therapy and/or anti-platelet therapy
- pre-existing gastrointestinal disorders which may interfere with absorption of drugs
- history of seizure disorders or unstable CNS metastases
- clinically significant cardiovascular disease
- history of long QT syndrome
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01143740
Start Date
June 1 2010
End Date
March 1 2011
Last Update
November 2 2016
Active Locations (4)
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1
Bordeaux, France, 33076
2
Lille, France, 59020
3
Lyon, France, 69373
4
Villejuif, France, 94805