Comparison of Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CM

• Conditions: Chronic myelogenous leukemia (CML); MedDRA version: 17.0Level: LLTClassification code 10009012Term: Chronic myelogenous leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003780-50-DE
• Lead Sponsor: Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-07
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

1. Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed for = 6 months.
2. Diagnosis of chronic phase as defined (prior to any anti-cancer treatment) by all of the following:
a. < 15% blasts in peripheral blood and bone marrow
b. < 20% basophils in peripheral blood and bone marrow
c. < 30% blasts + promyelocytes in peripheral blood and bone marrow
d. Platelets = 100x1000000000/L
e. No extramedullary disease (except liver or spleen)
3. Adequate hepatic and renal function defined as:
a. AST/ALT = 2.5 x upper limit of normal (ULN) or = 5 x ULN if attributable to liver involvement of leukemia.
b. Total bilirubin = 2.0 x ULN (unless associated with Gilbert’s syndrome)
c. Creatinine = 1.5 x ULN
4. Able to take oral tablets.
5. ECOG performance status of 0 or 1.
6. Age = 18 years (=20 in Japan only).
7. Recovered to = grade 1 or baseline from any toxicities of prior anti-cancer treatment.
8. Negative serum pregnancy test within two weeks of the first dose of test article if the subject is a woman of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
9. Willingness of all subjects who are not surgically sterile or postmenopausal to agree and commit to the use of a reliable method of birth control for the duration of the study and for 28 days after the last dose of test article.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 445
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

Exclusion Criteria

1. Philadelphia chromosome negative CML.
2. Prior anti-leukemia treatment. Up to six months of prior hydroxyurea or anagrelide treatment is allowed.
3. Identified stem cell donor with transplant planned within 12 months of randomization.
4. Prior stem cell transplant
5. Central nervous system (CNS) leukemia. (Subjects with symptoms of CNS leukemia must have a negative lumbar puncture prior to randomization)
6. Extramedullary disease only
7. History of accelerated or blast phase CML.
8. Major surgery or radiotherapy within 14 days of randomization.
9. Concomitant use of or need for medications known to prolong the QT interval
10. History of clinically significant or uncontrolled cardiac disease including:
• history of or active congestive heart failure
• uncontrolled angina or hypertension within 3 months
• myocardial infarction (within 12 months)
• clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
• diagnosed or suspected congenital or acquired prolonged QT syhistory of or prolonged QTc
• unexplained syncope
11. Prolonged QTc (> 0.45; average of triplicate readings at screening)
12. Recent or ongoing clinically significant gastrointestinal disorder.
13. Female subjects who are pregnant or breastfeeding.
14. Known seropositivity to HIV, current acute or chronic hepatitis B (hepatitis B surface antigen positive), hepatitis C, or cirrhosis.
15. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
16. Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval.
17. History of radiation therapy to greater than 25% of bone marrow.
18. Congenital or acquired cytopenia predating CML diagnosis (e.g. congenital neutropenia or immune thrombocytopenia).
19. Unstable or severe uncontrolled medical condition, evidence of serious active infection, significant psychiatric illness, or any important medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the risk associated with the subject’s participation in the study.

Study & Design

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