A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: Trabectedin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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