Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
1 other identifier
interventional
39
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2015
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedStudy Start
First participant enrolled
August 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2016
CompletedResults Posted
Study results publicly available
February 18, 2019
CompletedNovember 19, 2019
November 1, 2019
1 year
May 12, 2015
October 17, 2018
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in QTcF (QT Corrected According to Fridericia's Formula)
ΔQTCF (Change in QTcF); EOI (end of infusion); LSM (Least Square Means); PK (Pharmacokinetic(s)). On Day 1 (D1) of Cycle 1 (C1), LSM ΔQTcF should have low difference values, without any clear trend to change with time. Therefore, the upper bound (UB) of the (two-sided) 90%Confidence Interval (CI) at all time points had to be less than the protocol-specified cut-off of 20 ms at each time point. If so, non-inferiority of any ECG time point to baseline with respect of QTc prolongation could be concluded
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 (3)
Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Plasma Concentration)
Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Predicted ΔQTcF)
Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Intercept)
Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
Study Arms (1)
A (lurbinectedin)
EXPERIMENTALlurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaMarlead
Study Sites (16)
Sarcoma Oncology Research Center
Santa Monica, California, 90403, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Dana Farber Cancer lnstitute
Boston, Massachusetts, 02215, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Cancer Therapy & Research Center
San Antonio, Texas, 78229, United States
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario 12 de Octubre
Madrid, 280035, Spain
Hospital Ramón Y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Complejo Hospitalario de Especialidades Virgen de La Victoria
Málaga, 29010, Spain
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitari I Politècnic La Fe
Valencia, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
MeSH Terms
Interventions
Results Point of Contact
- Title
- Clinical Development Department of PharmaMar's Oncology Business Unit
- Organization
- Pharma Mar, S.A.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2015
First Posted
May 21, 2015
Study Start
August 12, 2015
Primary Completion
August 19, 2016
Study Completion
August 19, 2016
Last Updated
November 19, 2019
Results First Posted
February 18, 2019
Record last verified: 2019-11