An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Sarcoma
Both
Sarcoma
Trial Information
An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
Outcome Time Frame:
from baseline to week 12
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
NP22890
NCT ID:
NCT01143740
Start Date:
June 2010
Completion Date:
March 2011
Related Keywords:
- Sarcoma
- Liposarcoma
- Sarcoma
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