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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01254136
• Other study ID #: INCB 7839-204
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 1, 2010
• Last updated: January 20, 2012
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Overall objective response rate assessed by RECIST criteria		Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)	No