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

An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01143740

Enrollment

Registered

2010-06-14

Start date

2010-06-30

Completion date

2011-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

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.

Interventions

DRUGRO5045337

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026