NCT01764087

A Study of KX2-391 With Paclitaxel in Patients With Solid Tumors

An Open-label Phase I/II Study of KX2-391 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the maximum tolerated dose (MTD) of KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in combination with paclitaxel in patients who are diagnosed as gastric and breast cancer, respectively in Phase II.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific
• Gastric Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	KX2-391 and Paclitaxel	A treatment cycle in phase I will consist of 28 days, according to the following schedule: KX2-391 20 mg PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle. The trial will initially test the combination of weekly paclitaxel and KX2-391 given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort, this intervention will be terminated A treatment cycle in phase II will consist of 28 days, according to the following schedule: KX2-391 MTD PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-12-01
• Completion: 2016-05-01
• First posted: 2013-01-09
• Last updated: 2015-05-18

Locations

2 sites across 1 country: South Korea