Trial record 1 of 1 for:    NCT00568750
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Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00568750
First received: December 5, 2007
Last updated: December 8, 2013
Last verified: December 2013

December 5, 2007
December 8, 2013
December 2007
November 2011   (final data collection date for primary outcome measure)
Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria [ Time Frame: at 4 weeks compared to baseline ] [ Designated as safety issue: No ]
Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria at 4 weeks compared to baseline
Complete list of historical versions of study NCT00568750 on ClinicalTrials.gov Archive Site
  • Best response as assessed by CT scan/MRI [ Time Frame: according to RECIST criteria ] [ Designated as safety issue: No ]
  • Best response as assessed by fusion PET/CT scan [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
  • Clinical benefit [ Time Frame: Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: calculated from registration until progression or death due to tumor ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: calculated from registration until progression or death ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: calculated from registration until premature trial treatment termination due to any reason ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Overall survival will be calculated from registration until death or last follow-up, up to 5 years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Best response as assessed by CT scan/MRI according to RECIST criteria
  • Best response as assessed by fusion PET/CT scan
  • Clinical benefit
  • Time to progression
  • Progression-free survival
  • Time to treatment failure
  • Overall survival
  • Adverse drug reactions according to NCI CTCAE v3.0
  • Mutational status of KIT and PDGFR
  • Best response to second-line treatment with another TK-inhibitor
  • Time to progression while on second-line treatment with another TK-inhibitor
Not Provided
Not Provided
 
Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
47
December 2016
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   France,   Germany,   Switzerland
 
NCT00568750
SAKK 56/07, SWS-SAKK-56/07, EU-20789, EUDRACT-2007-002047-24, CDR0000577496
No
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Study Chair: Michael Montemurro, MD Centre Hospitalier Universitaire Vaudois
Swiss Group for Clinical Cancer Research
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP