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Clinical Trial Summary

Prospective, open-label, two-way crossover, phase Ib drug-drug interaction study in patients with advanced solid tumors


Clinical Trial Description

Prospective, open-label, two-way crossover, phase Ib drug-drug interaction study in patients with advanced solid tumors. The study will include a pre-treatment (screening) phase (within 14 days before the first lurbinectedin or itraconazole administration) followed by a treatment phase consisting of two lurbinectedin cycles, one cycle in combination with itraconazole and one cycle as single agent (in different order depending on the study sequence), and one additional third cycle of lurbinectedin as a single agent for patients who meet the continuation criteria and obtain a clinical benefit after the first two cycles, and then follow-up of adverse events if any. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05063318
Study type Interventional
Source PharmaMar
Contact Pharma Mar, S.A.
Phone +34918234647
Email [email protected]
Status Recruiting
Phase Phase 1
Start date October 7, 2020
Completion date December 1, 2022

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