drugset / Trial / NCT01173913

Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir

NCT01173913 ↗

Phase 1 Completed 57 enrolled The Netherlands Cancer Institute
RandomizedCrossoverOpen-labelTreatment

Summary

Oral administration has many advantages above intravenously administrated drugs for patients. Up to now, oral administration of docetaxel as single agent has not been feasible due to low and variable bioavailability. This low systematic exposure to docetaxel can effectively be increased after co-administration of ritonavir. The department of pharmacy of the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel, ModraDoc001 10 mg capsules. Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic exposure after administration of those forms is now being investigated.

Timeline

Start
2010-09
Primary completion
2016-10-04
Completion
2017-01-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 20 mg Oral
Subject Docetaxel Small molecule 30 mg Oral
Subject Docetaxel Small molecule 40 mg Oral
Subject Docetaxel Small molecule 80 mg Oral
Subject Ritonavir Other / unclassified 100 mg —
Subject Ritonavir Other / unclassified 200 mg —

Indications