MedTrace Logo

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

NCT00864175 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-01-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bijyoyesh Mookerjee, MD · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-06-30
Completion
2011-10-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864175 on ClinicalTrials.gov