Study Stopped
Incyte suspended development of the compound.
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
1 other identifier
interventional
68
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Jul 2007
Typical duration for phase_1 breast-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJanuary 18, 2018
January 1, 2018
3.9 years
January 26, 2009
January 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
Monthly
Study Arms (4)
Treatment A - INCB007839 and Trastuzumab
EXPERIMENTALINCB007839 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 B - INCB007839 and Trastuzumab
EXPERIMENTALINCB007839 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 C - INCB007839 and Trastuzumab
EXPERIMENTALINCB007839 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 D - INCB007839 and Docetaxel
EXPERIMENTALINCB007839 300mg BID with docetaxel
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Visakhapatnam, Andhra Pradesh, India
Unknown Facility
New Delhi, Ansari Nagar, India
Unknown Facility
Mangalore, Attavar, India
Unknown Facility
Bangalore, Karnataka, India
Unknown Facility
Hyderabaad, Punjagutta, India
Unknown Facility
Bangalore, Ram Nagar, India
Unknown Facility
Delhi, Rohini, India
Unknown Facility
Delhi, Vasundhara Enclave, India
Unknown Facility
Bhopal, India
Unknown Facility
Kolkata, India
Unknown Facility
Nashik, India
Unknown Facility
Pune, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bijyoyesh Mookerjee, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2009
First Posted
March 18, 2009
Study Start
July 1, 2007
Primary Completion
June 1, 2011
Study Completion
October 1, 2011
Last Updated
January 18, 2018
Record last verified: 2018-01