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

NCT ID: NCT01143740

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

RO5045337

Intervention Type DRUG

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

Interventions

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RO5045337

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Bordeaux, , France

Site Status

Lille, , France

Site Status

Lyon, , France

Site Status

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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2009-015522-10

Identifier Type: -

Identifier Source: secondary_id

NP22890

Identifier Type: -

Identifier Source: org_study_id