A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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