Back to resultsA Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Primary Purpose
Sarcoma
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
RO5045337
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
Secondary Outcome Measures
Safety and tolerability: Adverse events, laboratory parameters, ECG
Tumor response according to RECIST criteria assessed by CT or MRI
Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01143740
Brief Title
A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Official Title
An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO5045337
Intervention Description
orally day 1-10 each 28-day cycle, 3 cycles
Primary Outcome Measure Information:
Title
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
Time Frame
from baseline to week 12
Secondary Outcome Measure Information:
Title
Safety and tolerability: Adverse events, laboratory parameters, ECG
Time Frame
up to approximately 4 months after study start
Title
Tumor response according to RECIST criteria assessed by CT or MRI
Time Frame
from baseline to week 7
Title
Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers
Time Frame
multiple sampling weeks 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Lille
ZIP/Postal Code
59020
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
12. IPD Sharing Statement
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A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
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