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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

May 31, 2016

Conditions
Unspecified Adult Solid Tumor, Protocol SpecificGastric CancerBreast Cancer
Interventions
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."

Trial Locations (2)

463-707

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

110-744

RECRUITING

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Hanmi Pharmaceutical Company Limited

INDUSTRY

NCT01764087 - A Study of KX2-391 With Paclitaxel in Patients With Solid Tumors | Biotech Hunter | Biotech Hunter