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Trial record 1 of 1 for:    NCT01143740
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A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01143740
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 11, 2010
First Posted Date  ICMJE June 14, 2010
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE June 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2010)
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses) [ Time Frame: from baseline to week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01143740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2010)
  • Safety and tolerability: Adverse events, laboratory parameters, ECG [ Time Frame: 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 ]
  • Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers [ Time Frame: multiple sampling weeks 1 and 2 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Official Title  ICMJE An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: RO5045337
orally day 1-10 each 28-day cycle, 3 cycles
Study Arms  ICMJE Experimental: Single Arm
Intervention: Drug: RO5045337
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01143740
Other Study ID Numbers  ICMJE NP22890
2009-015522-10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP