Ranolazine to treat early cardiotoxicity induced by antitumor drugs - ND

Conditions: Patients who completed standard dose chemotherapy for the treatment of non-Hodgkin lymphoma or the adjuvant treatment of breast cancer or colorectal cancer.
MedDRA version: 9.1Level: HLGTClassification code 10025322
MedDRA version: 9.1Level: PTClassification code 10006200
MedDRA version: 9.1Level: PTClassification code 10009944
MedDRA version: 9.1Level: PTClassification code 10038038

Registration Number: EUCTR2009-016930-29-IT

Lead Sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age 18-70 years 2. Eastern Cooperative Oncology Group performance status of 0 to 1 3. total serum bilirubin < 2.0 mg/dL 4. serum creatinine level < 2.0 mg/dL 5. normal ECG 6. LVEF ≥ 50% at echocardiography 7. normal E/A and DcT at echocardiography 8. no significant perfusion defect at SPECT 9. able to release written informed consent 10. women of childbearing potential must have a negative serum pregnancy test; they agree on avoiding pregnancy by adequate contraceptive precautions (e.g., double barrier methods), or abstinence, during both chemotherapy and subsequent ranolazine therapy (if applicable) 11. male patients are informed of the mutagenic and embryotoxic effects of chemotherapy; in agreement with their partner, they accept not to concur in a pregnancy by adopting adequate contraceptive precautions, or abstinence, during chemotherapy.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. pregnancy or nursing 2. women with HER-2+ breast cancer requiring post-chemotherapy trastuzumab 3. prior chemotherapy or medastinal irradiation 4. patients with mediastinal lymphoma liable to irradiation after completing chemotherapy 5. long QTc, LVEF < 50% or altered E/A, or significant perfusion defects, at screening ECG, echocardiography, and SPECT 6. hypertension 7. any clinically documented heart disease 8. any other medical conditions that required treatment over the past 3 months with ACEI, ABR, Ca2+ antagonists, β blockers, nitrates, diuretics 9. diabetes mellitus 10. dislipidemia 11. BMI > 30 12. prior steroid pulse therapy for unrelated diseases 13. severe renal impairment 14. moderate or severe hepatic impairment 15. cerebral vascular accidents within the past 3 months 16. severe psychopathy 17. chronic obstructive lung disease