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

Hoffmann-La Roche20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma

Interventions

RO5045337DRUG

orally day 1-10 each 28-day cycle, 3 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Bordeaux, France

Unnamed facility

Lille, France

Unnamed facility

Lyon, France

Unnamed facility

Villejuif, France

Outcomes

Primary Outcomes

Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)

Time frame: from baseline to week 12

Secondary Outcomes

Safety and tolerability: Adverse events, laboratory parameters, ECG

Time frame: up to approximately 4 months after study start

Tumor response according to RECIST criteria assessed by CT or MRI

Time frame: from baseline to week 7

Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers

Time frame: multiple sampling weeks 1 and 2

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.