A muulticenter study to evaluate drug response for the treatment of a white blood cell cancer in early chronic phase

Phase 1

• Conditions: Ph+, BCR-ABL+ chronic myeloid leukemia (CML) in early chronic phase; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 14.1Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-002787-25-IT
• Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-27
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- Age = 18 - Male or female patients with diagnosis of Ph+ and/or BCR-ABL+ CML - Early chronic phase (within 6 months from diagnosis) - Pretreatment with Hydroxyurea or Anagrelide for a duration of up to 3 months and/or pretreatment with Imatinib for up to 30 days are permitted - Normal serum levels of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements prior to the first dose of study medication - Written informed consent prior to any study procedures being performed - AST and ALT = 2.5 x ULN or = 5.0 x ULN if considered due to leukaemia - Alkaline phosphatase = 2.5 x ULN unless considered due to leukaemia - Total direct bilirubin = 1.5 x ULN, except know Mb. Gilbert - Serum creatinine = 1.5 x ULN
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Known impaired cardiac function, including any of the following: - LVEF < 45% - Complete left bundle branch block - Right bundle branch block plus left anterior hemiblock, bifascicular block - Use of a ventricular-paced pacemaker - Congenital long QT syndrome - History of or presence of clinically significant ventricular or atrial tachyarrhythmias - Clinically significant resting bradycardia (<50 beats per minute) - QTc>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not within normal ranges before otinib dosing, electrolytes should be corrected and then the patient rescreened for QTc criterion. - Myocardial infarction within 12 months prior to starting study drugs - Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension) - Serum lipase and amylase > 1.5 x ULN (upper limit of normal) or history of acute (i.e., within 1 year of starting study medication) or chronic pancreatitis - Other concurrent uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol - Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery) - Concomitant medications with potential QT prolongation - Concomitant medications known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8) - Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy - Patients who are pregnant or breast feeding, or women of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of nilotinib). - Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. - Patients unwilling or unable to comply with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified