Overview

This trial is active, not recruiting.

Condition advanced or metastatic her2-negative breast cancer
Treatments ruxolitinib, capecitabine, placebo
Phase phase 2
Targets JAK, JAK1, JAK2
Sponsor Incyte Corporation
Start date March 2014
End date February 2016
Trial size 148 participants
Trial identifier NCT02120417, INCB 18424-268

Summary

This is a randomized, double-blind, placebo controlled clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who receive treatment with capecitabine in combination with ruxolitinib versus those who receive treatment with capecitabine alone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
ruxolitinib Jakafi ®
5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)
capecitabine
Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 BID (starting dose) Day 1-14 of each 21 day cycle
(Active Comparator)
capecitabine
Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 BID (starting dose) Day 1-14 of each 21 day cycle
placebo
5 mg matching placebo tablets to be administered by mouth

Primary Outcomes

Measure
Overall Survival (OS)
time frame: Randomization until death due to any cause. Approximately 29 months.

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 29 months.
Objective Response Rate
time frame: Randomization through end of study. Approximately 29 months.
Clinical Benefit Rate
time frame: Baseline through end of study. Approximately 29 months.
Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
time frame: Baseline through approximately 30 days post treatment discontinuation. Approximately 29 months.
Duration of Response
time frame: Baseline through end of study. Approximately 29 months.

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast - Locally advanced (Stage 3B) or metastatic (Stage 4) disease - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease - Subjects with hormone-receptor positive tumors must have failed available appropriate lines of hormonal therapy - ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities - Radiographically measurable or evaluable disease - An mGPS of 1 or 2 as defined below: - Criteria: 1. mGPS of 1: CRP > 10 mg/L and albumin ≥ 35 g/L 2. mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L Exclusion Criteria: - Received prior treatment with capecitabine for metastatic disease - Received more than 2 prior chemotherapy regimens for advanced or metastatic disease (not including neoadjuvant/adjuvant therapy) - Unknown hormone-receptor status - Ongoing radiation therapy, radiation therapy administered within 2 weeks of enrollment - Inadequate renal, hepatic or bone marrow function

Additional Information

Official title A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.