Trial Phase : Phase 1 .
Enrollment Quota : 25 .
Specialties:
Internal Medicine: Clinical Pharmacology,Hematology/Oncology
Oncology: Pharmacology/Therapy
Pharmacy: Chemotherapy/Oncology
Sponsor: PharmaMar
Study Start Date: September 2015
Estimated Completion Date: June 2016
Interventions
•Drug: lurbinectedin (PM01183)
Inclusion criteria
•Voluntarily signed and dated informed consent
•Normal cardiac conduction and function (centrally read)
•Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic
•Specific serum electrolyte levels
Exclusion criteria
•Age > 65 years
•Performance status = 2 [Eastern Cooperative Oncology Group (ECOG)]
•Heart rhythm disturbances
•Significant ischemic coronary disease, heart failure, myocardial infarction, or unstable angina within the last six months
•Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) > 450 mg/m²
Study Locations And Contact Information:
•1, Santa Monica California
Description:
Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected solid tumors.
