drugset / Trial / NCT03892018

The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol

NCT03892018 ↗

Phase 1 Terminated 29 enrolled Athenex, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.

Timeline

Start
2019-08-05
Primary completion
2023-05-12
Completion
2023-05-12

Outcome

Outcome not reported

Stopped (Business): “STUDY HALTED DUE TO FINANCIAL CONTRAINTS”

Drugs

EvaluationDrugModalityDoseRoute
Comparator HM30181AK-US Unknown — —
Comparator Paclitaxel Small molecule — —

Indications