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

Phase 1

Completed

• Conditions: Sarcoma
• Interventions: Drug: RO5045337

• Registration Number: NCT01143740
• Lead Sponsor: Hoffmann-La Roche

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	RO5045337	-

Primary Outcome Measures

Name	Time	Method
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)	from baseline to week 12

Secondary Outcome Measures

Name	Time	Method
Tumor response according to RECIST criteria assessed by CT or MRI	from baseline to week 7
Safety and tolerability: Adverse events, laboratory parameters, ECG	up to approximately 4 months after study start
Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers	multiple sampling weeks 1 and 2