Trial SAKK 56/07 Dasatinib first-line treatment in gastrointestinal stromal tumors. A multicenter phase II trial. - SAKK 56/07 (DaFLiG)

Conditions: GIST (Gastrointestinal stromal tumor) is a rare disease affecting 15 patients per 1 million individuals and comprising 5% of all sarcomas. Mutations in the genes of KIT or PDGFRA lead to constitutive activation of the encoded receptor and are the pathogenetic reason for the development of clinical GIST. GIST is a potentially curable disease, if complete resection of localized tumor is possible. Inoperable GIST cannot be cured at present.
MedDRA version: 9.1Level: LLTClassification code 10051066Term: Gastrointestinal stromal tumour

Registration Number: EUCTR2007-002047-24-FR

Lead Sponsor: Swiss Group for Clinical Cancer Reaserch (SAKK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 52

Inclusion Criteria

• Patient has histologically proven diagnosis of GIST
• Positive PET/CT with [18F]-fluorodeoxyglucose uptake of the target lesion(s), performed within 2 weeks prior to registration. Imaging data have been transmitted in DICOM format to the CHUV.
•Patient must have measurable disease by conventional scans (CT or MRI) performed within 2 weeks prior to registration. Imaging data have been stored on a CD-ROM in DICOM format.
•WHO performance status 0-2
•Age = 18 years
•Adequate hematological values: hemoglobin = 90 g/l (this may be achieved by transfusion if needed); neutrophils = 1.5 x 109/l; platelets =100 x 109/l.
•Adequate hepatic function: bilirubin = 2 x ULN; AP = 2.5 x ULN; ASAT and/or ALAT = 2.5 x ULN.
•Women are not breastfeeding, are using contraception if sexually active and of childbearing potential, are not pregnant and agree not to become pregnant during participation in the trial or during the 12 months thereafter. A negative pregnancy test before inclusion into the trial is required for all women < 50 years (unless considered unnecessary by the investigator).
Men agree not to father a child during participation in the trial or during the 12 months thereafter and use effective contraception method.
•Patient’s condition, compliance and geographic proximity allow proper staging, complete treatment and follow-up.
•Patient must give written informed consent before registration
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
•Previous therapy against GIST (particularly tyrosine kinase inhibitors at any time)
•Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 30 days prior to trial entry
•Signs or history of CNS metastases
•Hypocalcemia: serum Ca++ = LLN
•Clinically significant cardiovascular disease, including uncontrolled hypertension, congestive heart failure within 6 months prior to registration, QTc > 450 msec or major conduction abnormality (unless a cardiac pacemaker is present).
•Concurrent medical condition which could impair the ability of the patient (at the judgment of the investigator) to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes) or which may increase the risk of toxicity, including:
a)pleural or pericardial effusion of any grade
b)clinically significant coagulation or platelet function disorder (e.g. known
von Willebrand’s disease)
c)infection requiring intravenous antibiotics
d)ongoing significant gastrointestinal bleeding
e)nausea, vomiting or malabsorption syndrome which could interfere with ingestion
or absorption of oral drug
•Known hypersensitivity to trial drug
•Any concomitant drugs contraindicated for use with the trial drug according to the dasatinib investigator’s brochure[45].

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of dasatinib treatment as assessed by fusion PET/CT-scan;Secondary Objective: Efficacy and safety of dasatinib in GIST <br>To correlate efficacy of dasatinib with KIT and PDGRF mutation status<br>To correlate efficacy and safety with dasatinib drug exposure<br>Efficacy of second-line treatment with another TK-inhibitor <br>;Primary end point(s): Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria at 4 weeks compared to baseline

Secondary Outcome Measures

Name	Time	Method

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