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lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion

lurbinectedin (PM01183)

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.

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

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

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

ΔQTcF (Change from Baseline in QT Corrected According to Fridericia's Formula); CI (Confidence Interval); Cmax (Maximum Plasma Concentration).

Table below details the results of the linear mixed effects model to quantify the relationship between the lurbinectedin plasma concentrations and ΔQTcF and Predicted ΔQTcF and 90% CI at mean lurbinectedin Cmax.

PharmaMar

lurbinectedin (PM01183) is presented as a lyophilized powder for concentrate for solution for infusion with strength of 4 mg / vial.

Lurbinectedin was administered at a dose of 3.2 mg/m² given as a 1-hour i.v. every three weeks (q3wk) (three weeks = one treatment cycle).

Group A - Lurbinectedin (PM01183)

lurbinectedin (PM01183) is presented as a lyophilized powder for concentrate for solution for infusion with strength of 4 mg / vial.

Lurbinectedin was administered at a dose of 3.2 mg/m² given as a 1-hour i.v. every three weeks (q3wk) (three weeks = one treatment cycle). QTc interval duration was assessed when the patient was treated with lurbinectedin for the first time.

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Spain

Region of Enrollment

Clinical Development Department of PharmaMar's Oncology Business Unit

Cycle 1 - 5 min before EOI

Cycle 1 - 30 min after EOI

Cycle 1 - 1 hour after EOI

Cycle 1 - 3 hour after EOI

Cycle 1 - 24 hour after EOI

Cycle 1 - 72 hour after EOI

Cycle 1 - 168 hour after EOI

Cycle 2 - Before start of infusion

Cycle 2 - 5 min before EOI

Cycle 2 - 30 min after EOI

Cycle 2 - 1 hour after EOI

Cycle 2 - 3 hour after EOI

Cycle 2 - 168 hour after EOI

Change in QTcF (QT Corrected According to Fridericia's Formula)

Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Plasma Concentration)

Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Predicted ΔQTcF)

Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Intercept)

Overall Study

Spots Global Cancer Trial Database for Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

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