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NCT Number: NCT01143740

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

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5045337

Drug

orally day 1-10 each 28-day cycle, 3 cycles

Primary outcomes

  1. Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)

    Time frame: from baseline to week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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