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: 9.1 Level: HLGT Classification code 10025322 MedDRA version: 9.1 Level: PT Classification code 10006200 MedDRA version: 9.1 Level: PT Classification code 10009944 MedDRA version: 9.1 Level: PT Classification code 10038038
Conditions
Interventions
Trade Name: Ranolazine
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Ranolazine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 375-
Trade Nam
Sponsors
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years 2. Eastern Cooperative Oncology Group performance status of 0 to 1 3. total serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: Efficacy of five weeks ranolazine on post-chemotherapy diastolic dysfunction at echocardiography, and/or PDS at SPECT, and/or Nt-proBNP elevation. Safety: Objective and subjective tolerability of five weeks ranolazine in post-chemotherapy cancer patients;Secondary Objective: 1. Objective and subjective tolerability of six months ranolazine in post-chemotherapy cancer patients 2. Objective and subjective tolerability of five weeks to six months ranolazine in comparison with best standard of therapy. 3. This study is designed to prospectively assess: 3.1 The apparent incidence of cardiotoxicity (symptomatic or at laboratory tests) among patients exposed to standard dose chemotherapy regimens. 3.2 Mechanistic relations of reversible perfusion defects with diastolic dysfunction at echocardiography and/or Nt-proBNP or TnI levels in cancer patients. 3.3 Efficacy of five weeks to six months ranolazine at reducing the incidence of any cardiac event (symptomatic or at laboratory tests) in comparison with patients who remained on standard institutional follow-up. 3.4 To evaluate the incidence of cardiotoxicity in the study s global population (patients on ranolazine, best standard of therapy, standard institutional follow-up).;Primary end point(s): Efficacy: Efficacy will be evaluated as improvement or disappearance of abnormalities detected at the post-chemotherapy assessment. To evaluate the efficacy of 5 weeks ranolazine, the abnormalities detected in a given patient at the post-chemotherapy assessment will be compared to the same abnormalities detected in that patient at the 5 weeks early reassessment. Safety: The tolerability of 5 weeks ranolazine will be evaluated by describing all drug-related adverse events such as constipation, nausea, dizziness or any abnormality at laboratory tests. | — |
Countries
Italy
Outcome results
None listed