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

January 16, 2018 updated by: Incyte Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bhopal, India
      • Kolkata, India
      • Nashik, India
      • Pune, India
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India
    • Ansari Nagar
      • New Delhi, Ansari Nagar, India
    • Attavar
      • Mangalore, Attavar, India
    • Karnataka
      • Bangalore, Karnataka, India
    • Punjagutta
      • Hyderabaad, Punjagutta, India
    • Ram Nagar
      • Bangalore, Ram Nagar, India
    • Rohini
      • Delhi, Rohini, India
    • Vasundhara Enclave
      • Delhi, Vasundhara Enclave, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
  • Measurable disease as defined by the RECIST criteria
  • Life expectancy greater than or equal to 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Received any anticancer medications in the 28 days prior to enrollment into this study
  • Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
  • History of deep venous thrombosis within the last year
  • Contraindication to low dose warfarin therapy
  • Clinically significant cardiomyopathy
  • Prior treatment with INCB007839 or trastuzumab or lapatinib

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A - INCB007839 and Trastuzumab

INCB007839 100 mg BID and trastuzumab

In Cycle 1, 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: INCB007839
100 mg BID
Drug: INCB007839
200 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.
Experimental: Treatment B - INCB007839 and Trastuzumab

INCB007839 200 mg BID and trastuzumab

In Cycle 1, 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: INCB007839
100 mg BID
Drug: INCB007839
200 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.
Experimental: Treatment C - INCB007839 and Trastuzumab

INCB007839 300 mg BID and trastuzumab

In Cycle 1, 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: INCB007839
100 mg BID
Drug: INCB007839
200 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.
Experimental: Treatment D - INCB007839 and Docetaxel
INCB007839 300mg BID with docetaxel
Drug: Docetaxel
Drug: INCB007839
100 mg BID
Drug: INCB007839
200 mg BID
Drug: INCB007839
300 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
Time Frame: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
Time Frame: Monthly

For Cycle 1, PK samples to be collected on Day 8 and Day 15 at pre-dose the morning dose of INCB007839. For Cycles 2, 3 and 4, PK will be collected as a single sample, obtained at pre-dose, on Day 1. PK samples will not be collected at Cycle 5 or later.

o. For Cycle 1, PD samples to be collected at time of screening and at pre-dose on Day 1, Day
Monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Bijyoyesh Mookerjee, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 7839-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe