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

November 1, 2016 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
      • Lille, France, 59020
      • Lyon, France, 69373
      • Villejuif, France, 94805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: RO5045337
orally day 1-10 each 28-day cycle, 3 cycles

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability: Adverse events, laboratory parameters, ECG
Time Frame: up to approximately 4 months after study start
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
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
multiple sampling weeks 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP22890
  • 2009-015522-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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