A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies

NCT01967043 ↗

Phase 1 Completed 34 enrolled Kinex Pharmaceuticals Inc. Atlantic Research Group · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.

Timeline

Start: 2013-10
Primary completion: 2016-02
Completion: 2016-09

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HM30181AK	Unknown	15 mg	Oral
Subject	Paclitaxel	Small molecule	30 mg	Oral

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies

Summary

Timeline

Drugs

Indications