Prospective, open-label, two-way crossover, phase Ib drug-drug interaction study in patients with advanced solid tumors
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.
| Condition | Advanced Solid Tumors |
|---|---|
| Treatment | Lurbinectedin alone, Lurbinectedin+Itraconazole co-administration |
| Clinical Study Identifier | NCT05063318 |
| Sponsor | PharmaMar |
| Last Modified on | 1 February 2023 |
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