Overview

This trial is active, not recruiting.

Condition gastrointestinal stromal tumor
Treatment dasatinib
Phase phase 2
Target BCR-ABL
Sponsor Swiss Group for Clinical Cancer Research
Start date December 2007
End date November 2011
Trial size 47 participants
Trial identifier NCT00568750, CDR0000577496, EU-20789, EUDRACT-2007-002047-24, SAKK 56/07, SWS-SAKK-56/07

Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria
time frame: at 4 weeks compared to baseline

Secondary Outcomes

Measure
Best response as assessed by CT scan/MRI
time frame: according to RECIST criteria
Best response as assessed by fusion PET/CT scan
time frame: at 4 weeks
Clinical benefit
time frame: Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST
Time to progression
time frame: calculated from registration until progression or death due to tumor
Progression-free survival
time frame: calculated from registration until progression or death
Time to treatment failure
time frame: calculated from registration until premature trial treatment termination due to any reason
Overall survival
time frame: Overall survival will be calculated from registration until death or last follow-up, up to 5 years.
Adverse drug reactions according to NCI CTCAE v3.0
time frame: Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0.

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed gastrointestinal stromal tumor (GIST) - Measurable disease by conventional scans (CT scan or MRI) within 2 weeks prior to study registration - Positive PET/CT scan with [^18F]-fluorodeoxyglucose uptake of the target lesions within 2 weeks prior to study registration - No signs or history of CNS metastases PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Hemoglobin ≥ 90 g/L (transfusion allowed) - Neutrophil count ≥ 1.5 x 10^9/L - Platelet count ≥ 100 x 10^9/L - Bilirubin ≤ 2 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 times ULN - AST and/or ALT ≤ 2.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 12 months after completion of study therapy - No other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer - No hypocalcemia (i.e., serum calcium ≤ lower limit of normal) - No clinically significant cardiovascular disease, including any of the following: - Uncontrolled hypertension - Congestive heart failure within the past 6 months - QTc > 450 msec or major conduction abnormality (unless a cardiac pacemaker is present) - No concurrent medical condition (e.g., active autoimmune disease or uncontrolled diabetes) that would impair the ability of the patient to participate in the study (at the judgment of the investigator) or that may increase the risk of toxicity, including any of the following: - Pleural or pericardial effusion of any grade - Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease) - Infection requiring intravenous antibiotics - Ongoing significant gastrointestinal bleeding - Nausea, vomiting, or malabsorption syndrome that could interfere with ingestion or absorption of oral dasatinib - No known hypersensitivity to study drug PRIOR CONCURRENT THERAPY: - No prior therapy for GIST, particularly tyrosine kinase inhibitors at any time - More than 30 days since prior participation in a clinical trial - At least 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following: - Itraconazole, ketoconazole, miconazole, and voriconazole - Amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, and ritonavir - Ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, imatinib mesylate, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, and telithromycin - At least 7 days since prior and no concurrent medications known to prolong the QT interval, including any of the following: - Quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, and dofetilide - Erythromycin and clarithromycin - Chlorpromazine, haloperidol, mesoridazine, thioridazine, and pimozide - Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine - No concurrent IV bisphosphonates during the first 8 weeks of study treatment - No other concurrent experimental drugs or anticancer therapy - No concurrent drugs contraindicated for use with dasatinib, according to the dasatinib investigator's brochure

Additional Information

Official title Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial
Description OBJECTIVES: Primary - To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors. Secondary - To determine the efficacy and safety of dasatinib in these patients. - To correlate the efficacy of dasatinib with KIT and PDGFR mutational status. - To correlate the efficacy and safety of dasatinib with dasatinib drug exposure. - To determine the efficacy of second-line treatment with another TK-inhibitor. OUTLINE: This is a multicenter study. Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Swiss Group for Clinical Cancer Research.