NCT03987685

Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies

A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Athenex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, nonrandomized, open-label, safety, tolerability and pharmacokinetic (PK) study to determine the MTD and optimal dosing of Oratopo. No control group has been included.

Detailed description

This is a multicenter, open-label, safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid tumor malignancies. In the treatment period groups of 3 to 6 subjects will receive a single dose of oral Oratopo will be administered and will be followed for toxicity. Dose escalation will continue until an MTD is reached, or nonlinear increases in exposure are confirmed, or a maximum dose of Oratopo is reached.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Oratopo	Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets

Timeline

• Start date: 2018-07-19
• Primary completion: 2021-01-09
• Completion: 2021-01-09
• First posted: 2019-06-17
• Last updated: 2022-02-16

Locations

3 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study