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Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00568750
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : June 17, 2019
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Drug: dasatinib Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial
Actual Study Start Date : January 22, 2008
Actual Primary Completion Date : January 18, 2012
Actual Study Completion Date : May 16, 2018

Arm Intervention/treatment
Experimental: Dasatinib Drug: dasatinib
Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).
Other Name: Sprycel

Primary Outcome Measures :
  1. Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria [ Time Frame: at 4 weeks compared to baseline ]

Secondary Outcome Measures :
  1. Best response as assessed by CT scan/MRI [ Time Frame: according to RECIST criteria ]
  2. Best response as assessed by fusion PET/CT scan [ Time Frame: at 4 weeks ]
  3. Clinical benefit [ Time Frame: Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST ]
  4. Time to progression [ Time Frame: calculated from registration until progression or death due to tumor ]
  5. Progression-free survival [ Time Frame: calculated from registration until progression or death ]
  6. Time to treatment failure [ Time Frame: calculated from registration until premature trial treatment termination due to any reason ]
  7. Overall survival [ Time Frame: Overall survival will be calculated from registration until death or last follow-up, up to 5 years. ]
  8. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00568750

Show Show 18 study locations
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Michael Montemurro, MD Centre Hospitalier Universitaire Vaudois
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00568750    
Other Study ID Numbers: SAKK 56/07
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Swiss Group for Clinical Cancer Research:
gastrointestinal stromal tumor
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action