Pharmacologic interaction between Ifosfamide and Aprepitant in treated patients with soft tissue sarcoma.
- Conditions
- Soft tissue sarcoma (localized, local recidive or metastatic)MedDRA version: 20.0Level: PTClassification code 10075333Term: Soft tissue sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004814-24-FR
- Lead Sponsor
- INSTITUT CLAUDIUS REGAUD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 52
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:
a) Hemoglobin > 9.0 g/dL, Neutrophils > 1500/mm3, Platelets > 100000/mm3
b) Creatinine clearance (MDRD formula) > 60ml/min.
c) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
a. Active infection
b. Active hepatitis or cirrhosis
c. 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method