Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

• Status: Completed
• Trial end date: 2016-08-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaMar

Criteria

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