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View of NCT02451007 on 2016_02_08
| ClinicalTrials Identifier: | NCT02451007 |
|---|---|
| Updated: | 2016_02_08 |
Descriptive Information | |
| Brief title | 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 |
| 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. | |
| Detailed description | |
| Phase | Phase 1 |
| Study type | Interventional |
| Study design | Other |
| Study design | Open Label |
| Study design | Single Group Assignment |
| Study design | Safety Study |
| Primary outcome | Measure: Change in QTcF (QT corrected according to Fridericia formula) Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2 Safety Issue? Yes Description:Difference in QT corrected by Fridericia's method (QTcF) between each scheduled post-dose ECG time point and baseline at Cycle 1 (ΔQTcF). |
| Secondary outcome | Measure: Relationship ΔQTcF / PM01183 plasma concentration Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2 Safety Issue? Yes |
| Secondary outcome | Measure: Changes in response rate (RR) Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2 Safety Issue? Yes |
| Secondary outcome | Measure: Changes in heart rate Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2 Safety Issue? Yes |
| Secondary outcome | Measure: Changes in QRS interval Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2 Safety Issue? Yes |
| Secondary outcome | Measure: Changes in PR interval Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2 Safety Issue? Yes |
| Enrollment | 25 (Anticipated) |
| Condition | Solid Tumors |
| Arm/Group |
Arm Label: A (lurbinectedin) Experimental
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion |
| Intervention |
Drug: lurbinectedin (PM01183) Arm Label: A (lurbinectedin)
|
Recruitment Information | |
| Status | Recruiting |
| Start date | 2015-08 |
| Primary completion date | 2016-06 (Anticipated) |
| 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 | |
| Gender | Both |
| Maximum age | 65 Years |
| Healthy volunteers | No |
Administrative Data | |
| Organization name | PharmaMar |
| Organization study ID | PM1183-B-005-14-QT |
| Sponsor | PharmaMar |
| Health Authority | United States: Food and Drug Administration |