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

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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

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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: RO5045337 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Study Start Date : June 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Arm Drug: RO5045337
orally day 1-10 each 28-day cycle, 3 cycles




Primary Outcome Measures :
  1. Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses) [ Time Frame: from baseline to week 12 ]

Secondary Outcome Measures :
  1. Safety and tolerability: Adverse events, laboratory parameters, ECG [ Time Frame: up to approximately 4 months after study start ]
  2. Tumor response according to RECIST criteria assessed by CT or MRI [ Time Frame: from baseline to week 7 ]
  3. Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers [ Time Frame: multiple sampling weeks 1 and 2 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143740


Locations
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France
Bordeaux, France, 33076
Lille, France, 59020
Lyon, France, 69373
Villejuif, France, 94805
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01143740     History of Changes
Other Study ID Numbers: NP22890
2009-015522-10
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Liposarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma