Soft Tissue SarcomaPhase 4IPIAP-STMNCT03514381
Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma
A Phase 4 study testing Patients starting a treatment with Doxorubicin and Ifosfamide in people with Soft Tissue Sarcoma, run by Institut Claudius Regaud at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Patients starting a treatment with Doxorubicin and Ifosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesFrance
- Study dates
- 18 May 2018to 23 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or metastatic).
- Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative treatment).
- Screening laboratory values must meet the following criteria:
- Hemoglobin > 9.0 g/dL, Neutrophils > 1500/mm3, Platelets > 100000/mm3
- Creatinine clearance (MDRD formula) > 60ml/min.
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- AST/ALT < 2.5 x ULN (5 x ULN in patients with hepatic metastasis).
- Evaluable disease (measurable per RECIST or not), if applicable.
- Patient must provide written informed consent prior to any study specific procedures.
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- Previous treatment with Ifosfamide.
- Patient who has already started doxorubicin and ifosfamide treatment.
- Any medical condition that can increase the patient's risk
- Active infection
- Active hepatitis or cirrhosis
- Recipients of organ transplants or immunocompromised patients, including Human Immunodeficiency Virus (HIV) infection
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- Pregnant or breastfeeding women
- Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
- Patient protected by law
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Bergonie
Bordeaux, 33076
Institut Regional Du Cancer de Montpellier (Icm)
Montpellier, 34298
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Patients starting a treatment with Doxorubicin and Ifosfamide
- Keywords
- Soft Tissue Sarcoma, Ifosfamide, Aprepitant, Doxorubicin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients starting a treatment with Doxorubicin and IfosfamideDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients starting a treatment with Doxorubicin and Ifosfamide | Other | Not described Receives: Drug: Patients starting a treatment with Doxorubicin and Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Cycle 2 Day 3 for each patient
Secondary outcomes (3)
Toxicity assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Measured: Cycle 3 Day 1 for each patient
Evolution of plasma concentrations of ifosfamide and its serum metabolites between the first and second cycles
Measured: Cycle 3 Day 1 for each patient
The rate of objective responses determined according to the criteria RECIST v 1.1
Measured: Cycle 3 Day 1 for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start18 May 2018
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514381
- Sponsor's protocol ID
- 17 SARC 04
- Acronym
- IPIAP-STM
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2018
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valentin T, Lambert M, Chaltiel L, Allal B, Mseddi M, Yakoubi M, Chevreau C, Toulmonde M, Firmin N, Filleron T, Chatelut E. Population pharmacokinetic analysis reveals no impact of aprepitant on the pharmacokinetics of ifosfamide, 2-dechloroifosfamide, and 3-dechloroifosfamide. Eur J Pharm Sci. 2023 Jun 1;185:106420. doi: 10.1016/j.ejps.2023.106420. Epub 2023 Mar 5.
PubMed 36882147
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03514381
- Acronym / sponsor ID
- IPIAP-STM / 17 SARC 04
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft Tissue Sarcoma, Ifosfamide, Aprepitant, Doxorubicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients starting a treatment with Doxorubicin and Ifosfamide | Other | Drug: Patients starting a treatment with Doxorubicin and Ifosfamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or metastatic).
- Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative treatment).
- Screening laboratory values must meet the following criteria:
- Evaluable disease (measurable per RECIST or not), if applicable.
Key exclusion criteria (9 listed)
- Previous treatment with Ifosfamide.
- Patient who has already started doxorubicin and ifosfamide treatment.
- Any medical condition that can increase the patient's risk
- Pregnant or breastfeeding women
- Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients starting a treatment with Doxorubicin and Ifosfamide9 blood samples will be collected at each Cycle: * Cycle 1 (Day 1-Day 2-Day 3) * Cycle 2 (Day 1-Day 2-Day 3) | Drug | Patients starting a treatment with Doxorubicin and Ifosfamide |
Primary outcome
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
3 secondary outcomes
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
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
The rate of objective responses determined according to the criteria RECIST v 1.1
Time frame: Cycle 3 Day 1 for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 36882147Valentin T, Lambert M, Chaltiel L, Allal B, Mseddi M, Yakoubi M, Chevreau C, Toulmonde M, Firmin N, Filleron T, Chatelut E. Population pharmacokinetic analysis reveals no impact of aprepitant on the pharmacokinetics of ifosfamide, 2-dechloroifosfamide, and 3-dechloroifosfamide. Eur J Pharm Sci. 2023 Jun 1;185:106420. doi: 10.1016/j.ejps.2023.106420. Epub 2023 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patients starting a treatment with Doxorubicin and Ifosfamide in people with Soft Tissue Sarcoma, run by Institut Claudius Regaud at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.