Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients with Solid Tumors

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000206-18-ES

Enrollment

Registered

2015-07-10

Start date

2015-09-10

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Product Name: Lurbinectedin 4 mg powder for concentrate for solution for infusion Product Code: PM01183 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: lurb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) To be enrolled in clinical trial PM1183-B-005-14 2) Voluntarily signed and dated informed consent to participate in this QT evaluation study 3) Qualifying 12-lead ECG (between Day -10 and Day -2 before first IMP administration) consistent with normal cardiac conduction and function, that will be read by the central laboratory, showing: a) Sinus rhythm. b) Heart rate between 45 and 100 beats per min (bpm). c) QTcF ? 500 ms. d) QRS interval =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Age > 65 years 2) Eastern Cooperative Oncology Group performance status (ECOG PS) = 2 * 3) Heart rhythm disturbances (e.g., atrial fibrillation), unusual T wave and U wave (if present) morphology, personal or family history of Long QT Syndrome, complete left bundle branch block, permanent ventricular pacemaker, or Brugada Syndrome 4) Significant ischemic coronary disease, New York Heart Association (NYHA) class III or IV congestive heart failure, myocardial infarction, or unstable angina within the last six months 5) Any skin condition likely to interfere with ECG electrode placement, or history of breast implant or thoracic surgery likely to cause abnormality in electrical conduction 6) Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) > 450 mg/m² 7) Patients who are at screening on QT-prolonging medication (rated as 1 at APPENDIX 1: Lists of drugs that prolong the QT interval and/or induce torsades de pointes ventricular arrhythmia), if it cannot be interrupted at least 48 hours before each ECG assessment * Note that PM1183-B-005-14 eligibility criteria permit ECOG PS ? 2.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the potential effects of PM01183 at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), in patients with selected solid tumors.;Secondary Objective: - To characterize the PM01183 plasma concentration/QTc relationship - To explore related ECG parameters;Primary end point(s): Change in QTcF: Difference in QT corrected by Fridericia?s method (QTcF) between each scheduled post-dose ECG time point and baseline at Cycle 1 (?QTcF);Timepoint(s) of evaluation of this end point: Along the study	—

Measure

Time frame

Main Objective: To assess the potential effects of PM01183 at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), in patients with selected solid tumors.;Secondary Objective: - To characterize the PM01183 plasma concentration/QTc relationship - To explore related ECG parameters;Primary end point(s): Change in QTcF: Difference in QT corrected by Fridericia?s method (QTcF) between each scheduled post-dose ECG time point and baseline at Cycle 1 (?QTcF);Timepoint(s) of evaluation of this end point: Along the study

—

Secondary

Measure	Time frame
Secondary end point(s): - Relationship ?QTcF / PM01183 plasma concentration: concentration-effect relationship for PM01183 will be evaluated - Change in other ECG parameters: changes in response rate (RR), heart rate,QRS, and PR will be explored;Timepoint(s) of evaluation of this end point: Along the study	—

Countries

Spain, United States

Contacts

Public ContactClinical Trials

Pharma Mar, S.A. Sociedad Unipersonal

clinicaltrials@pharmamar.com+3491846 60 87

Outcome results