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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

INCB007839

Intervention Type DRUG

100 mg BID

trastuzumab

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

INCB007839

Intervention Type DRUG

200 mg BID

trastuzumab

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

INCB007839

Intervention Type DRUG

300 mg BID

trastuzumab

Intervention Type DRUG

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.

Treatment D - INCB007839 and Docetaxel

INCB007839 300mg BID with docetaxel

Group Type EXPERIMENTAL

INCB007839

Intervention Type DRUG

300 mg BID

Docetaxel

Intervention Type DRUG

Interventions

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INCB007839

100 mg BID

Intervention Type DRUG

INCB007839

200 mg BID

Intervention Type DRUG

INCB007839

300 mg BID

Intervention Type DRUG

INCB007839

300 mg BID

Intervention Type 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.

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No