Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma (IPIAP-STM)

April 9, 2026 updated by: Institut Claudius Regaud

This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant.

The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Montpellier, France, 34298
        • Institut Regional Du Cancer de Montpellier (Icm)
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer de Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or metastatic).
  3. Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative treatment).

  4. Screening laboratory values must meet the following criteria:

    1. Hemoglobin > 9.0 g/dL, Neutrophils > 1500/mm3, Platelets > 100000/mm3
    2. Creatinine clearance (MDRD formula) > 60ml/min.
    3. AST/ALT < 2.5 x ULN (5 x ULN in patients with hepatic metastasis).
  5. Evaluable disease (measurable per RECIST or not), if applicable.
  6. Patient must provide written informed consent prior to any study specific procedures.
  7. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

  1. Previous treatment with Ifosfamide.
  2. Patient who has already started doxorubicin and ifosfamide treatment.

  3. Any medical condition that can increase the patient's risk

    1. Active infection
    2. Active hepatitis or cirrhosis
    3. Recipients of organ transplants or immunocompromised patients, including Human Immunodeficiency Virus (HIV) infection
  4. Pregnant or breastfeeding women
  5. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
  6. Patient protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients starting a treatment with Doxorubicin and Ifosfamide
Drug: Patients starting a treatment with Doxorubicin and Ifosfamide

9 blood samples will be collected at each Cycle:

  • Cycle 1 (Day 1-Day 2-Day 3)
  • Cycle 2 (Day 1-Day 2-Day 3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of 2d-Ifo plasma concentrations between the 1st cycle (without co-exposure to the Aprepitant) and the 2nd cycle (with co-exposure to the Aprepitant)
Time Frame: Cycle 2 Day 3 for each patient
Cycle 2 Day 3 for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Time Frame: Cycle 3 Day 1 for each patient
Cycle 3 Day 1 for each patient
Evolution of plasma concentrations of ifosfamide and its serum metabolites between the first and second cycles
Time Frame: Cycle 3 Day 1 for each patient
Cycle 3 Day 1 for each patient
The rate of objective responses determined according to the criteria RECIST v 1.1
Time Frame: Cycle 3 Day 1 for each patient
Cycle 3 Day 1 for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2018

Primary Completion (Actual)

November 23, 2020

Study Completion (Actual)

November 23, 2020

Study Registration Dates

First Submitted

April 20, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17 SARC 04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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