A Placebo-Controlled Study Evaluating the Potential Effects of Trabectedin on the Heart in Patients With Advanced Cancer
The purpose of the study is to determine the effects of trabectedin on the heart's electrical cycle as measured by an electrocardiogram in patients with advanced cancer. The study will also assess the safety of trabectedin and the way trabectedin is used by the body in patients with advanced cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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|
- QT interval measured by a 12-lead ECG [ Time Frame: Up to Day 2 ] [ Designated as safety issue: No ]
- Type and number of treatment-emegent adverse events [ Time Frame: Up to 30 days after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
trabectedin 3-hour placebo i.v. infusion on one day and trabectedin 1.3 mg/m2 3-hour i.v. infusion on another day (2 consecutive days of treatment) (single-blind). Patients may continue treatment with trabectedin until clinical benefit or drug is commercially available (open-label).
3-hour placebo i.v. infusion on one day and trabectedin 1.3 mg/m2 3-hour i.v. infusion on another day (2 consecutive days of treatment) (single-blind). Patients may continue treatment with trabectedin until clinical benefit or drug is commercially available (open-label).
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.
|United States, Florida|
|Miami, Florida, United States|
|United States, North Carolina|
|Charlotte, North Carolina, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, Washington|
|Tacoma, Washington, United States|
|Bangalore N/A, India|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Moscow, Russian Federation|
|Moscow N/A, Russian Federation|
|St Petersburg N/A, Russian Federation|
|St-Petersburg, Russian Federation|
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|