Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma (IPIAP-STM)
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|ClinicalTrials.gov Identifier: NCT03514381|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : October 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Patients starting a treatment with Doxorubicin and Ifosfamide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma|
|Actual Study Start Date :||May 18, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
|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:
- 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 ]
- 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 ]
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): NCT03514381
|Bordeaux, France, 33076|
|Institut Regional Du Cancer de Montpellier (Icm)|
|Montpellier, France, 34298|
|Institut Universitaire Du Cancer de Toulouse - Oncopole|
|Toulouse, France, 31059|