A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a single-blind (where the participant does not know the treatment he receives),
      multicenter (study conducted at multiple sites), placebo-controlled (an inactive substance
      that is compared with the study medication to test whether the study medication has a real
      effect in clinical study), sequential design (it is a design in a single group of
      Participants where one or more study medication is administered in a sequence) study to
      evaluate the potential effects of a single-dose administration of trabectedin on the QT
      intervals of the electrocardiogram (ECG). Initially, the study will consist of 2 phases: a
      screening phase (within 21 days before administration of the study medication), and a
      single-blind treatment phase (for 2 days). Participants who complete the single-blind
      treatment phase will be opted to take trabectedin in an open-label extension (for a minimum
      of 6 cycles), as long as they derive a clinical benefit (ie, until there is clear evidence of
      disease progression or unacceptable toxicity, as judged by the investigator). Participants
      will be assessed for ECG on predose before the single-blind treatment phase. During the
      single-blind treatment phase, a placebo control will be given on Day 1, and trabectedin (1.3
      mg per square meter) will be administered on Day 2. Participants will be monitored until
      completion of the 24 hour pharmacokinetic blood sample collection. During the open-label
      extension (21 days after completion of the single-blind treatment phase), all Participants
      will receive trabectedin intravenously on Day 1 of each 17- to 49 day treatment cycle. The
      dose and schedule of trabectedin will be modified according to the type of malignancy being
      treated (ie, sarcoma, ovarian, or breast cancer). Safety evaluations will include assessment
      of adverse events, vital signs, physical examination, and clinical laboratory tests which
      will be performed throughout the study. The study duration for the open-label extension will
      vary by participant.
    

Intervention name(s): Trabectedin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Trabectedin will be administered as 1.3 mg/m2 3-hour intravenous infusion on Day 2.; Participants will receive 3-hour placebo intravenous infusion on Day 1.
Intervention MeSH terms: Trabectedin
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Solid tumor; Advanced solid tumor; Malignant tumors; Sarcoma; Breast tumor; Ovarian tumor; QT interval; Trabectedin; Yondelis; Ecteinascidin 743; ET743