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

NCT01254136 | Terminated Phase 1

• 1 other identifier: INCB 7839-204
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.

  Measured monthly starting at Baseline (estimated duration 6-9 months)

Secondary Outcomes (1)

• Overall objective response rate assessed by RECIST criteria

  Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)

Study Arms (1)

Treatment A - INCB007839 300mg BID

EXPERIMENTAL

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.

Drug: INCB007839 300mg BID; Drug: Trastuzumab; Drug: Vinorelbine

Interventions

INCB007839 300mg BID DRUG

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.

Treatment A - INCB007839 300mg BID

Trastuzumab DRUG

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.

Treatment A - INCB007839 300mg BID

Vinorelbine DRUG

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.

Treatment A - INCB007839 300mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (14)

Unknown Facility

Fayetteville, Arkansas, United States

Location

Unknown Facility

Duarte, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Davie, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

Lake Success, New York, United States

Location

Unknown Facility

Huntersville, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BID protein, human; Trastuzumab; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Denise A. Yardley, MD

  Sara Cannon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 6, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (14)