Phase 2
N=75
A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00786838 ↗Enrolled (actual)
75
Serious AEs
41.3%
Results posted
Jan 2014
Primary outcome: Primary: The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction — 3.6; -6.2 milli seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trabectedin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction |
3.6; -6.2 | — |
| PRIMARY The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett's Correction |
0.1; -1.5 | — |
| SECONDARY Maximum Plasma Concentration of Trabectedin (Cmax) |
9.24 | — |
| SECONDARY Time Taken to Acheive Maximum Plasma Concentration (Tmax) |
2.22 | — |
| SECONDARY Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds |
2; 2; 4; 6 | — |
| SECONDARY Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With QTc Interval Greater Than 450 Milli Seconds |
6; 4; 21; 23 | — |
| SECONDARY Number of Participants With QTc Interval Greater Than 480 Milli Seconds |
0; 0; 1; 2 | — |
| SECONDARY Number of Participants With QTc Interval Greater Than 500 Milli Seconds |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With PR Interval Greater Than 200 Milli Seconds |
3; 2 | — |
| SECONDARY Number of Participants With QRS Interval Greater Than 120 Milli Seconds |
1; 1 | — |
| SECONDARY Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose |
76.9; 82.6 | — |
Summary
The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.
Eligibility Criteria
Inclusion Criteria
- Participants with locally advanced or metastatic solid tumors who have received three or less prior lines of systemic chemotherapy
- Participants must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
- Normal cardiac conduction and function as documented on a 12-lead electrocardiogram
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Adequate organ function as evidenced by laboratory tests
- Able to receive dexamethasone or its equivalent
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria
- Participants treated with more than three prior chemotherapy regimens (including adjuvant therapy)
- Previous exposure to trabectedin
- Central nervous system (CNS) metastasis
- Known hypersensitivity to any of the components of the trabectedin intravenous formulation or dexamethasone
- Heart rhythm disturbances, unusual T wave and U wave (if present) morphology, blood pressure outside of normal range, a history of cardiac failure, myocardial infarction, or cardiomyopathy, or a history of additional risk factors for torsade de pointes (eg, heart failure, electrolyte abnormalities, family history of Long QT Syndrome)
- Participants who at screening are on medication that is known to prolong the QT interval or who is on CYP3A4 inhibitors or inducers
Data sourced from ClinicalTrials.gov (NCT00786838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.