Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Li… (NCT00756509) | Clinical Trial Compass
CompletedPhase 4
Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib
Finland, France, Germany34 participantsStarted 2008-08-29
Plain-language summary
The purpose of this multicenter, single-arm, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Potassium ≥ LLN,
✓. Magnesium ≥ LLN,
✓. Phosphorus ≥ LLN,
✓. Total calcium (corrected for serum albumin) ≥ LLN
✓. ALT and AST ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if considered due to tumor;
✓. Alkaline phosphatase ≤ 2.5 x ULN unless considered due to tumor;
Exclusion criteria
✕. LVEF \< 45% or below the institutional LLN range (whichever is higher) as determined by echocardiogram at Visit 1
✕. Complete left bundle branch block
✕. Use of a ventricular paced cardiac pacemaker
✕. Congenital long QT syndrome or family history of long QT syndrome
✕. History of or presence of significant ventricular or atrial tachyarrhythmias
✕. Clinically significant resting bradycardia (\< 50 beats per minute)
✕. QTc \> 450 msec on screening ECG (using the QTcF formula). If QTc \> 450 msec and electrolytes are not within normal ranges (electrolytes should be corrected and then the patient rescreened for QTc.
What they're measuring
1
Proportion of Participants With Best Overall Response at Month 6 (Core Phase) Determined According to the RECIST v1.0.