NCT02963168

A DRF Study to Evaluate Safety, Tolerability, PK, and Activity of Oradoxel Monotherapy in Subjects w Adv. Malignancies

A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Athenex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to determine the MTD and optimal dosing regimen of Oradoxel. 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 malignancies. Groups of 3 to 6 subjects will receive a single dose of Oradoxel and will be followed for toxicity. If non linearity in PK is observed, additional subjects will receive Oradoxel as 2 single daily doses once every three weeks. Subjects who tolerate the drug and have stable disease or better response will be eligible to receive ongoing treatment.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Oradoxel	oral docetaxel will be supplied in capsules and oral HM30181A-UK tablets

Timeline

• Start date: 2017-04-20
• Primary completion: 2020-03-30
• Completion: 2020-04-30
• First posted: 2016-11-15
• Last updated: 2019-10-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study