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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
INCB007839
INCB007839
INCB007839
INCB007839
trastuzumab
Docetaxel
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment A - INCB007839 and Trastuzumab

Treatment B - INCB007839 and Trastuzumab

Treatment C - INCB007839 and Trastuzumab

Treatment D - INCB007839 and Docetaxel

Arm Description

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.

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.

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.

INCB007839 300mg BID with docetaxel

Outcomes

Primary Outcome Measures

Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria

Secondary Outcome Measures

To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
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

Full Information

First Posted
January 26, 2009
Last Updated
January 16, 2018
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00864175
Brief Title
Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Incyte suspended development of the compound.
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A - INCB007839 and Trastuzumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment B - INCB007839 and Trastuzumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment C - INCB007839 and Trastuzumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment D - INCB007839 and Docetaxel
Arm Type
Experimental
Arm Description
INCB007839 300mg BID with docetaxel
Intervention Type
Drug
Intervention Name(s)
INCB007839
Intervention Description
100 mg BID
Intervention Type
Drug
Intervention Name(s)
INCB007839
Intervention Description
200 mg BID
Intervention Type
Drug
Intervention Name(s)
INCB007839
Intervention Description
300 mg BID
Intervention Type
Drug
Intervention Name(s)
INCB007839
Intervention Description
300 mg BID
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
Description
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
Time Frame
Monthly

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bijyoyesh Mookerjee, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Visakhapatnam
State/Province
Andhra Pradesh
Country
India
City
New Delhi
State/Province
Ansari Nagar
Country
India
City
Mangalore
State/Province
Attavar
Country
India
City
Bangalore
State/Province
Karnataka
Country
India
City
Hyderabaad
State/Province
Punjagutta
Country
India
City
Bangalore
State/Province
Ram Nagar
Country
India
City
Delhi
State/Province
Rohini
Country
India
City
Delhi
State/Province
Vasundhara Enclave
Country
India
City
Bhopal
Country
India
City
Kolkata
Country
India
City
Nashik
Country
India
City
Pune
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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