Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

This study has been terminated.
(Incyte has suspended development of the compound.)
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01254136
First received: December 1, 2010
Last updated: January 20, 2012
Last verified: January 2012

December 1, 2010
January 20, 2012
October 2010
September 2011   (final data collection date for primary outcome measure)
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations. [ Time Frame: Measured monthly starting at Baseline (estimated duration 6-9 months) ] [ Designated as safety issue: Yes ]
Safety and tolerability of the treatment regimen as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations. [ Time Frame: Measured monthly starting at Baseline (estimated duration 6-9 months) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01254136 on ClinicalTrials.gov Archive Site
Overall objective response rate assessed by RECIST criteria [ Time Frame: Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.

This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.

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
Breast Cancer
  • Drug: INCB007839 300mg BID
    INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
  • Drug: Trastuzumab
    INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
  • Drug: Vinorelbine
    INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
Experimental: Treatment A - INCB007839 300mg BID
This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
Interventions:
  • Drug: INCB007839 300mg BID
  • Drug: Trastuzumab
  • Drug: Vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
October 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
  • Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
  • Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
  • Subject with presence of measurable disease based on RECIST 1.1
  • Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer

Exclusion Criteria:

  • Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
  • Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
  • Subject with current active malignancy other than breast cancer
  • Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
  • Subject with significant renal or hepatic dysfunction
  • Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
  • Subject with insufficient bone marrow function
  • Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
  • Subject with current active bacterial, Hepatitis B or C, and/or HIV infections
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01254136
INCB 7839-204
No
Incyte Corporation
Incyte Corporation
Not Provided
Principal Investigator: Denise A. Yardley, MD Sara Cannon Research Institute
Incyte Corporation
January 2012

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