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

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ClinicalTrials.gov Identifier: NCT00864175
Recruitment Status : Terminated (Incyte suspended development of the compound.)
First Posted : March 18, 2009
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: INCB007839 Drug: trastuzumab Drug: Docetaxel Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Arm Intervention/treatment
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.

Drug: INCB007839
100 mg BID
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.
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.

Drug: INCB007839
200 mg BID
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.
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.

Drug: INCB007839
300 mg BID
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.
Experimental: Treatment D - INCB007839 and Docetaxel
INCB007839 300mg BID with docetaxel
Drug: INCB007839
300 mg BID
Drug: Docetaxel



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination [ Time Frame: Monthly ]

    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




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864175


Locations
India
Visakhapatnam, Andhra Pradesh, India
New Delhi, Ansari Nagar, India
Mangalore, Attavar, India
Bangalore, Karnataka, India
Hyderabaad, Punjagutta, India
Bangalore, Ram Nagar, India
Delhi, Rohini, India
Delhi, Vasundhara Enclave, India
Bhopal, India
Kolkata, India
Nashik, India
Pune, India
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Bijyoyesh Mookerjee, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00864175     History of Changes
Other Study ID Numbers: INCB 7839-202
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action