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

Status:	Completed
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any - 65
Updated:	2/20/2019
Start Date:	August 12, 2015
End Date:	August 19, 2016

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

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.

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

We found this trial at

sites

Dana-Farber Cancer lnstitute

Boston, Massachusetts 02210

from

Boston, MA