search
Back to results

Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INCB007839 300mg BID
Trastuzumab
Vinorelbine
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:

  • Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
  • Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
  • Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
  • Subject with presence of measurable disease based on RECIST 1.1
  • Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer

Exclusion Criteria:

  • Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
  • Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
  • Subject with current active malignancy other than breast cancer
  • Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
  • Subject with significant renal or hepatic dysfunction
  • Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
  • Subject with insufficient bone marrow function
  • Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
  • Subject with current active bacterial, Hepatitis B or C, and/or HIV infections

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment A - INCB007839 300mg BID

Arm Description

This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.

Outcomes

Primary Outcome Measures

Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.

Secondary Outcome Measures

Overall objective response rate assessed by RECIST criteria

Full Information

First Posted
December 1, 2010
Last Updated
January 20, 2012
Sponsor
Incyte Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01254136
Brief Title
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
Official Title
A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Incyte has suspended development of the compound.
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 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 Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment A - INCB007839 300mg BID
Arm Type
Experimental
Arm Description
This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
Intervention Type
Drug
Intervention Name(s)
INCB007839 300mg BID
Intervention Description
INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
Primary Outcome Measure Information:
Title
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.
Time Frame
Measured monthly starting at Baseline (estimated duration 6-9 months)
Secondary Outcome Measure Information:
Title
Overall objective response rate assessed by RECIST criteria
Time Frame
Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2 Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions Subject with presence of measurable disease based on RECIST 1.1 Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer Exclusion Criteria: Subject with Left ventricular ejection fraction (LVEF) below institutional normal range Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable Subject with current active malignancy other than breast cancer Subject with prior history of other malignancy except for cancers from which the patient is currently disease free Subject with significant renal or hepatic dysfunction Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy Subject with insufficient bone marrow function Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy. Subject with current active bacterial, Hepatitis B or C, and/or HIV infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise A. Yardley, MD
Organizational Affiliation
Sara Cannon Research Institute
Official's Role
Principal Investigator
Facility Information:
City
Fayetteville
State/Province
Arkansas
Country
United States
City
Duarte
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Davie
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Lake Success
State/Province
New York
Country
United States
City
Huntersville
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Salt Lake
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

We'll reach out to this number within 24 hrs