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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.

Safety Issue:

No

Principal Investigator

Bijyoyesh Mookerjee, MD

Investigator Role:

Study Director

Investigator Affiliation:

Incyte Corporation

Authority:

United States: Food and Drug Administration

Study ID:

INCB 7839-202

NCT ID:

NCT00864175

Start Date:

July 2007

Completion Date:

October 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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