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
2 other identifiers
interventional
20
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 11, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedNovember 2, 2016
November 1, 2016
9 months
June 11, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
from baseline to week 12
Secondary Outcomes (3)
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
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Lille, 59020, France
Unknown Facility
Lyon, 69373, France
Unknown Facility
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2010
First Posted
June 14, 2010
Study Start
June 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11