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

Part of paid clinical trials in Santa Monica, California.

Sponsor
PharmaMar
Study ID
NCT02451007
Phase
PHASE2
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
N/A - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 12, 2015
Status verified
Nov 2019
Primary completion
Aug 19, 2016
Completion
Aug 19, 2016

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: A (lurbinectedin)
    lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion

Primary Outcome Measure

Change in QTcF (QT Corrected According to Fridericia's Formula) [ Time Frame: 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. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Sarcoma Oncology Research CenterSanta MonicaCalifornia90403-
University of Colorado Cancer CenterAuroraColorado80045-
Dana Farber Cancer lnstituteBostonMassachusetts02215-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Cancer Therapy & Research CenterSan AntonioTexas78229-

Find similar trials in Santa Monica, CA

By research site
Sarcoma Oncology Research Center· Santa Monica, CAUniversity of Colorado Cancer Center· Aurora, CODana Farber Cancer lnstitute· Boston, MAThe University of Texas MD Anderson Cancer Center· Houston, TXCancer Therapy & Research Center· San Antonio, TX

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