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Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

Phase 2
18 Years
Open (Enrolling)
Gastrointestinal Stromal Tumor

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Trial Information

Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial



- To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients
with gastrointestinal stromal tumors.


- 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.

Inclusion Criteria


- 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


- 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

- 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


- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria

Outcome Time Frame:

at 4 weeks compared to baseline

Safety Issue:


Principal Investigator

Michael Montemurro, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois


Switzerland: Swissmedic

Study ID:

SAKK 56/07



Start Date:

December 2007

Completion Date:

December 2016

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • gastrointestinal stromal tumor
  • Gastrointestinal Stromal Tumors