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A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

Phase 2
18 Years
65 Years
Not Enrolling
Neoplasm Metastases

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Trial Information

A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

This is a single-blind, placebo-controlled study to evaluate the potential effects of a
single-dose of tracbetedin on the heart's electrical cycle as measured by electrocardiograms
(ECGs) in patients with advanced cancer. Participation in the study will include a 21-day
screening period, plus two days of single-blinded treatment followed by an optional
open-label extension phase. During the single-blind treatment period (1 cycle) patients will
sequentially receive trabectedin for 1 day and placebo for 1 day and be monitored for safety
for up to 30 days. Only the investigator (physician conducting the study) and study staff
will know which treatment the patient receives during the single-blind phase. The open-label
phase is optional. The duration of the open-label extension will vary by patient. In this
phase, patients will receive trabectedin for as long as the investigator determines that the
patient is receiving benefit from the treatment, or until trabectedin becomes commercially
available for use, whichever is earlier. There are 2 treatment phases: Single-blind and
Open-Label. In the single-blind phase patients will receive one 3-hour intravenous (i.v.)
infusion of trabectedin (1.3 mg/m2) on one day and one 3-hour i.v. infusion of trabectedin
placebo on another day (treatments will be administered on 2 consecutive days). In the
Open-label extension phase, the dose and schedule of trabectedin may modified at the
discretion of the Investigator as appropriate depending on the type of malignancy diagnosed.

Inclusion Criteria:

- Patients with locally advanced or metastatic solid tumors who have received three or
less prior lines of systemic chemotherapy

- Patients who have relapsed or had progressive disease following standard of care
treatment with chemotherapy, or intolerant to prior standard of care treatment with

- Normal cardiac conduction and function as documented on a 12-lead ECG

- Adequate organ function as evidenced by laboratory tests

- Able to receive dexamethasone or its equivalent

Exclusion Criteria:

- Patients treated with more than three prior chemotherapy regimens (including adjuvant

- Previous exposure to trabectedin

- Central nervous system (CNS) metastasis

- 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 (e.g. heart failure, electrolyte abnormalities, family history of Long QT

- Patients who at screening are on medication that is known to prolong the QT interval
or who are on CYP3A4 inhibitors or inducers

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

QT interval measured by a 12-lead ECG

Outcome Time Frame:

Up to Day 2

Safety Issue:


Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

December 2009

Related Keywords:

  • Neoplasm Metastases
  • Solid tumors
  • Breast
  • Sarcoma
  • Ovarian
  • locally advanced
  • QT interval
  • Trabectedin
  • ET743
  • R279741
  • Ecteinascidin 743
  • Neoplasms
  • Neoplasm Metastasis



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