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

Incyte

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Docetaxel; Drug: INCB007839; Drug: trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00864175

INCB 7839-202

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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68 participants in 4 patient groups

Treatment A - INCB007839 and Trastuzumab

Experimental group

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.

Treatment:

Drug: INCB007839

Drug: trastuzumab

Drug: INCB007839

Drug: INCB007839

Drug: INCB007839

Treatment B - INCB007839 and Trastuzumab

Experimental group

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.

Treatment:

Drug: INCB007839

Drug: trastuzumab

Drug: INCB007839

Drug: INCB007839

Drug: INCB007839

Treatment C - INCB007839 and Trastuzumab

Experimental group

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.

Treatment:

Drug: INCB007839

Drug: trastuzumab

Drug: INCB007839

Drug: INCB007839

Drug: INCB007839

Treatment D - INCB007839 and Docetaxel

Experimental group

Description:

INCB007839 300mg BID with docetaxel

Treatment:

Drug: INCB007839

Drug: Docetaxel

Drug: INCB007839

Drug: INCB007839

Drug: INCB007839