NCT00864175

Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer

A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety of INCB007839 Combined With Trastuzumab in Patients With Previously Untreated HER2 Positive Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	INCB007839	100 mg BID
DRUG	INCB007839	200 mg BID
DRUG	INCB007839	300 mg BID
DRUG	INCB007839	300 mg BID
DRUG	trastuzumab	trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
DRUG	Docetaxel

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-06-01
• Completion: 2011-10-01
• First posted: 2009-03-18
• Last updated: 2018-01-18

Locations

12 sites across 1 country: India