Status:
COMPLETED
A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PharmaMar
Conditions:
Solid Tumor
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- Participants with locally advanced or metastatic solid tumors who have received three or less prior lines of systemic chemotherapy
- Participants must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
- Normal cardiac conduction and function as documented on a 12-lead electrocardiogram
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Adequate organ function as evidenced by laboratory tests
- Able to receive dexamethasone or its equivalent
- Agrees to protocol-defined use of effective contraception
Exclusion
- Participants treated with more than three prior chemotherapy regimens (including adjuvant therapy)
- Previous exposure to trabectedin
- Central nervous system (CNS) metastasis
- Known hypersensitivity to any of the components of the trabectedin intravenous formulation or dexamethasone
- 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 (eg, heart failure, electrolyte abnormalities, family history of Long QT Syndrome)
- Participants who at screening are on medication that is known to prolong the QT interval or who is on CYP3A4 inhibitors or inducers
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00786838
Start Date
October 1 2008
End Date
December 1 2009
Last Update
April 11 2014
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Miami, Florida, United States
2
Charlotte, North Carolina, United States
3
Philadelphia, Pennsylvania, United States
4
Tacoma, Washington, United States