Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Completed · Phase 2
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT02451007
- Run by
- PharmaMar
- People needed
- 39
- Starts
- 2015-08-12
- Expected to finish
- 2016-08-19
- Last updated by the study team
- 2019-11-19
Who can join
Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sarcoma Oncology Research Center — Santa Monica, California, United States
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Dana Farber Cancer lnstitute — Boston, Massachusetts, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Cancer Therapy & Research Center — San Antonio, Texas, United States
- Hospital Universitari Vall D'Hebron — Barcelona, Spain
- Complejo Hospitalario Regional Reina Sofía — Córdoba, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Hospital Ramón Y Cajal — Madrid, Spain
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
- Hospital Universitario Madrid Sanchinarro — Madrid, Spain
- Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Spain
- Complejo Hospitalario de Especialidades Virgen de La Victoria — Málaga, Spain
- Complexo Hospitalario Universitario de Santiago — Santiago de Compostela, Spain
- Hospital Universitari I Politècnic La Fe — Valencia, Spain
- Hospital Universitario Miguel Servet — Zaragoza, Spain
Full record on ClinicalTrials.gov
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