Under 65, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in QTcF (QT Corrected According to Fridericia's Formula)Primary· 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.
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
Cycle 1 - 5 min before EOI
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
3.32
1.12 – 5.51
Cycle 1 - 30 min after EOI
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
1.76
-0.41 – 3.93
Cycle 1 - 1 hour after EOI
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
1.84
-1.02 – 4.69
Cycle 1 - 3 hour after EOI
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
1.32
-1.40 – 4.05
Cycle 1 - 24 hour after EOI
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
-8.24
-11.2 – -5.26
Cycle 1 - 72 hour after EOI
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
-12.4
-15.4 – -9.39
Cycle 1 - 168 hour after EOI
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
-5.20
-7.98 – -2.41
Cycle 2 - Before start of infusion
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
-0.46
-3.27 – 2.35
Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Plasma Concentration)Secondary· Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
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.
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
2.06
1.42 – 2.71
Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Predicted ΔQTcF)Secondary· Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
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.
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
2.94
0.79 – 5.10
Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Intercept)Secondary· Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)
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.
Group
Value
95% CI
Group A - Lurbinectedin (PM01183)
-6.40
-8.44 – -4.35
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02454972 — Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
· Phase 2
· completed
NCT01980667 — Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors
· Phase 1
· completed
NCT01970540 — Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable
· Phase 1
· completed
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Other PharmaMar trials
Trials by the same sponsor.
NCT06088290 — Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants
· Phase 3
· recruiting
NCT05841563 — Clinical Trial of PM54 in Advanced Solid Tumors Patients.
· Phase 1
· recruiting
NCT05705167 — Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NE
· Phase 2
· terminated
NCT05121740 — Extension Study in a Cohort of Adult Patients With COVID-19 Infection
· Phase 1, PHASE2
· completed
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· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PharmaMar
Last refreshed: 19 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02451007.