A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

NCT02120417 | Terminated Phase 2 Results

• 1 other identifier: INCB 18424-268
• Study Type: interventional
• Target: 149
• Locations: 6 countries
• Sites: 106

Brief Summary

This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Overall Survival (OS)

  Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.

  Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.

• Median Survival

  Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.

  Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.

• Percentage of Participants Achieving Overall Survival

  Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.

  Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.

• Percentage of Participants Achieving Objective Response Rate

  Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

• Duration of Response (DOR)

  Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

• Percentage of Participants Achieving Clinical Benefit Rate

  Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

Study Arms (2)

Treatment A - Capecitabine and ruxolitinib

EXPERIMENTAL

Drug: Ruxolitinib; Drug: Capecitabine

Treatment B - Capecitabine and placebo

ACTIVE COMPARATOR

Drug: Capecitabine; Drug: Placebo

Interventions

Ruxolitinib DRUG

5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)

Also known as: Jakafi ®, Jakavi ®

Treatment A - Capecitabine and ruxolitinib

Capecitabine DRUG

Capecitabine 2000 mg/m\^2 daily given as 1000 mg/m\^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle

Treatment A - Capecitabine and ruxolitinib; Treatment B - Capecitabine and placebo

Placebo DRUG

5 mg matching placebo tablets to be administered by mouth

Treatment B - Capecitabine and placebo

Eligibility Criteria

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

You may qualify if:

• 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
• Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
• ≥ 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:
• modified Glasgow prognostic score (mGPS) of 1: CRP \> 10 mg/L and albumin ≥ 35 g/L
• mGPS of 2: C-reactive protein (CRP) \> 10 mg/L and albumin \< 35 g/L

You may not qualify if:

• Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
• Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
• Unknown hormone-receptor status
• Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
• Concurrent anticancer therapy
• Inadequate renal, hepatic or bone marrow function
• Another current or previous malignancy within 2 years of study entry unless approved by the sponsor

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (106)

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Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Sedona, Arizona, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Oxnard, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Quincy, Illinois, United States

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Springfield, Illinois, United States

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Urbana, Illinois, United States

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Ames, Iowa, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Grand Island, Nebraska, United States

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Omaha, Nebraska, United States

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Camden, New Jersey, United States

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Hackensack, New Jersey, United States

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Farmington, New Mexico, United States

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Albany, New York, United States

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Johnson City, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Goldsboro, North Carolina, United States

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Pinehurst, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Middletown, Ohio, United States

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Portland, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Bedford, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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Plano, Texas, United States

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Tyler, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Salem, Virginia, United States

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Seattle, Washington, United States

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Green Bay, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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La Roche-sur-Yon, France

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Paris, France

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Alba, Italy

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Fano, Italy

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Foggia, Italy

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Lecco, Italy

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Milan, Italy

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Naples, Italy

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Pontedera, Italy

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Roma, Italy

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Saronno, Italy

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Lisbon, Portugal

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A Coruña, Spain

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Barcelona, Spain

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Jaén, Spain

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Lleida, Spain

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Madrid, Spain

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Cardiff, United Kingdom

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Glasgow, United Kingdom

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Kingston upon Thames, United Kingdom

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London, United Kingdom

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Nottingham, United Kingdom

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Sutton, United Kingdom

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Taunton, United Kingdom

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Truro, United Kingdom

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Yeovil, United Kingdom

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

ruxolitinib; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

855 463-3463

Study Officials

• Gerard Kennealey, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 22, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 13, 2018
• Results First Posted: July 12, 2017

Record last verified: 2018-01

Locations

FR (2); US (80); PT (1); GB (9); IT (9); ES (5)