10 febrero 2016

PM01183 , Actualizada la Fase I : 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.

Un ensayo que se esta llevando a cabo en Cinco Hospitales de Estados Unidos y que esta previsto que termine en Junio de este año .


View of NCT02451007 on 2016_02_08

ClinicalTrials Identifier:NCT02451007
Updated:2016_02_08

Descriptive Information

Brief titleEvaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Official titleEvaluation 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
PhasePhase 1
Study typeInterventional
Study designOther
Study designOpen Label
Study designSingle Group Assignment
Study designSafety Study
Primary outcomeMeasure: 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 outcomeMeasure: Relationship ΔQTcF / PM01183 plasma concentration
Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2
Safety Issue? Yes
Secondary outcomeMeasure: Changes in response rate (RR)
Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2
Safety Issue? Yes
Secondary outcomeMeasure: Changes in heart rate
Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2
Safety Issue? Yes
Secondary outcomeMeasure: Changes in QRS interval
Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2
Safety Issue? Yes
Secondary outcomeMeasure: Changes in PR interval
Time Frame: Day 1 of cycle 1 and Day 1 of cycle 2
Safety Issue? Yes
Enrollment25 (Anticipated)
ConditionSolid 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

StatusRecruiting
Start date2015-08
Primary completion date2016-06 (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
GenderBoth
Maximum age65 Years
Healthy volunteersNo

Administrative Data

Organization namePharmaMar
Organization study IDPM1183-B-005-14-QT
SponsorPharmaMar
Health AuthorityUnited States: Food and Drug Administration