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

This study has been terminated.
(Incyte suspended development of the compound.)
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00864175
First received: January 26, 2009
Last updated: January 20, 2012
Last verified: January 2012
History of Changes

January 26, 2009
January 20, 2012
July 2007
June 2011   (final data collection date for primary outcome measure)
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria [ Time Frame: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864175 on ClinicalTrials.gov Archive Site
To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination [ Time Frame: Monthly ] [ Designated as safety issue: No ]

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
Relative changes of PD biomarkers after one, two, and four cycles of treatment [ Time Frame: One, two and four months following the initiation of treatment with INCB07839 and trastuzumab ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer
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

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: INCB007839 and trastuzumab
    100 mg BID
  • Drug: INCB007839 and trastuzumab
    200 mg BID
  • Drug: INCB007839 and trastuzumab
    300 mg BID
  • Drug: INCB007839 and Docetaxel
    300 mg BID
  • Experimental: 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.

    Intervention: Drug: INCB007839 and trastuzumab
  • Experimental: 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.

    Intervention: Drug: INCB007839 and trastuzumab
  • Experimental: 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.

    Intervention: Drug: INCB007839 and trastuzumab
  • Experimental: Treatment D - INCB007839 and Docetaxel
    INCB007839 300mg BID with docetaxel
    Intervention: Drug: INCB007839 and Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
68
October 2011
June 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00864175
INCB 7839-202
No
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Bijyoyesh Mookerjee, MD Incyte Corporation
Incyte Corporation
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP