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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00864175
• Other study ID #: INCB 7839-202
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 26, 2009
• Last updated: January 16, 2018
• Start date: July 2007
• Est. completion date: October 2011

Study information

• Verified date: January 2018
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• INCB007839
100 mg BID
• INCB007839
200 mg BID
• INCB007839
300 mg BID
• INCB007839
300 mg BID
• 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.
• Docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria		Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
Secondary	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	Monthly