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

Roche

Status and phase: Completed; Phase 1

Conditions: Sarcoma

Treatments: Drug: RO5045337

Study type: Interventional

Funder types: Industry

Identifiers

NCT01143740

NP22890

2009-015522-10

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: RO5045337