A Study of RO5045337 in Patients With Liposarcomas Prior... | NCT01143740

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

NCT01143740

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Sarcoma

Interventions

RO5045337

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-015522-10

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jun 11, 2010

First Submission Date that Met QC Criteria

Jun 11, 2010

First Posted Date

Jun 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental		Drug: RO5045337

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RO5045337	Drug	orally day 1-10 each 28-day cycle, 3 cycles	Single Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Bordeaux		33076	France