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A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS)

NCT02441309 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-09-13

Study results available
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Summary

This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. They will all either have surgery or a biopsy before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36 weeks of Mifamurtide treatment.

Conditions

Interventions

DRUG

Mifamurtide

DRUG

Ifosfamide

Sponsors & Collaborators

  • Millennium: The Takeda Oncology Company

    collaborator INDUSTRY

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • European Commission

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Bass Hassan, BMBCh FRCP · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-11-04
Completion
2016-11-04

Countries

  • Germany
  • Italy
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02441309 on ClinicalTrials.gov