Clinical trial NCT02451007: Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Official title: Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients With Selected Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumors
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 39
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in QTcF (QT Corrected According to Fridericia's Formula)
timeFrame: Scheduled post-baseline ECG time points were taken 5-10 min before their time-matched PK samples: i.e., 5 min before EOI, 30 min, 1, 3, 24, 72 and 168 hours after EOI of Cycle 1, and 5 min before EOI, 30 min, 1, 3 and 168 hours after EOI of Cycle 2.
Secondary outcomes:
measure: Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Plasma Concentration)
timeFrame: Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
measure: Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Predicted ΔQTcF)
timeFrame: Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
measure: Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Intercept)
timeFrame: Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Sarcoma Oncology Research Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Boston
country: United States
facility: Dana Farber Cancer lnstitute
state: Massachusetts
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center
state: Texas
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Córdoba
country: Spain
facility: Complejo Hospitalario Regional Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Málaga
country: Spain
facility: Complejo Hospitalario de Especialidades Virgen de La Victoria
city: Santiago De Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References: