Adjunction of cilostazol to imatinib for patients with an unresectable or metastatic GIST (Gatsrointestinal stromal tumor) already treated by imatinib or who will start a treatment with imatinib
- Conditions
- Gastrointestinal stromal tumors.Gastrointestinal stromal tumors (GISTs) start their development in special cells in the wall of the gastrointestinal (GI) tract, also known as the digestive tract.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001295-37-BE
- Lead Sponsor
- CUB HOPITAL ERASME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:
-histologically proven metastatic or locally advanced histologically proven non resectable GIST ( any primary tumor site) already treated by Glivec® (at any dose) for at least 12 months in first line therapy, or patients who will start Glivec® (at any dose) in first line therapy or after failure of all TKIs
-exon 11, exon 9 or other kit mutations
-written signed informed consent
-ability to take oral medication
-metabolic positivity of the tumor at the first PET-CT (positivity is defined as High 18F-FDG uptake by a lesion more than the surrounding tissue)
-at least one measurable lesion by CT scanner
-no contraindication to cilostazol
-ECOG performance status 0 /1 at study entry
-effective contraception for both male and female patients must be used for at least 8 weeks after the last study drug administration if the risk of conception exists
-age > 18 years old
-life expectancy at least 12 weeks
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
oSerum creatinine <1.5x upper reference range
oTotal bilirubin <1.5x ULN
oAlanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5x ULN (<5x ULN for patients with liver involvement of their cancer).
oAmylase and lipase <1.5x ULN.
oINR<1.5x ULN
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Exclusion Criteria:
-PDGFR&D842V mutation
-Wild-type tumors
-unability to take oral medication
-any malabsorption condition
-previous exposure to cilostazol or PDE3 inhibitor or any other phosphodiesterase inhibitor
-known hypersensitivity to any of the components of study treatments
-previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
-pregnancy or breast feeding
-medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
-patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study
- history of organ allograft
-ongoing infection HIV infection
-liver failure, cirrhosis Child Pugh B or C
-active chronic hepatitis B or C with a need for antiviral treatment
-heart failure any NYHA class
-grapefruit juice consumption
-hemodialysis
-active bleeding disorder or coagulation disorder
-uncontrolled concurrent CNS, cardiac, infectious diseases
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