Recruitment

Recruitment Status
Terminated
Estimated Enrollment
310

Inclusion Criterias

Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
...
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Radiographically measurable or evaluable disease
mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.

Exclusion Criterias

Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
...
Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
Received more than 1 prior regimen for advanced or metastatic disease.
Prior treatment with a JAK inhibitor for any indication.

Summary

Conditions
Pancreatic Cancer
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment g...

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups: Treatment A (N = 155): Capecitabine + ruxolitinib Treatment B (N = 155): Capecitabine + placebo Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.

Inclusion Criterias

Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
...
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Radiographically measurable or evaluable disease
mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.

Exclusion Criterias

Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
...
Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
Received more than 1 prior regimen for advanced or metastatic disease.
Prior treatment with a JAK inhibitor for any indication.

Locations

Taichung
New York, New York
Oshawa, Ontario
Newark, Delaware
Rome, Georgia
...
Taichung
New York, New York
Oshawa, Ontario
Newark, Delaware
Rome, Georgia
Miami, Florida
Thomasville, Georgia
Hollywood, Florida
Austin, Texas
Brugge
Louisville, Kentucky
Plymouth
Grand Junction, Colorado
Nyack, New York
Santa Monica, California
Niles, Illinois
Goshen, Indiana
Fresh Meadows, New York
Long Beach, California
Boulder, Colorado
Beaumont, Texas
Genova
Berlin
New Britain, Connecticut
Bethesda, Maryland
Tyler, Texas
Annapolis, Maryland
Essen
Guildford
Rockville, Maryland
Las Vegas, Nevada
New South Wales
Hamilton
Portland, Oregon
Taipei
Kortrijk
East Orange, New Jersey
Northridge, California
Brescia
El Paso, Texas
Surprise, Arizona
Worcester, Massachusetts
Saint Louis, Missouri
San Francisco, California
Salt Lake City, Utah
Marietta, Georgia
Atlanta, Georgia
Hot Springs, Arkansas
Eugene, Oregon
Covina, California
Seneca, South Carolina
Pisa
Leeds
Firenze
Pembroke Pines, Florida
Cartersville, Georgia
Fort Worth, Texas
Kalamazoo, Michigan
Whittier, California
Rimini
Waco, Texas
Urbana, Illinois
Baltimore, Maryland
Los Angeles, California
Aviano
Seattle, Washington
Colorado Springs, Colorado
Omaha, Nebraska
Phoenix, Arizona
Modesto, California
Lansing, Michigan
Hwasun-gun
Beverly Hills, California
Longmont, Colorado
Vancouver, Washington
Chattanooga, Tennessee
Cremona
Scarborough, Maine
Bolivar, Missouri
Spartanburg, South Carolina
Ratchathewi
Blacksburg, Virginia
Trumbull, Connecticut
Memphis, Tennessee
Glasgow
Montreal, Quebec
Newcastle upon Tyne
Downey, California
Christchurch
Gent
Bangor
Santa Maria, California
Dallas, Texas
Madison, Wisconsin
Binghamton, New York
Patumwan
San Diego, California
Topeka, Kansas
Papillion, Nebraska
Chandler, Arizona
Carrollton, Georgia
Harlow
Australian Capital Territory
London
Berkeley, California
Avondale, Arizona
Tualatin, Oregon
Gilroy, California
Douglasville, Georgia
Charleston, South Carolina
Bari
Aalst
Nottingham
San Luis Obispo, California
San Antonio, Texas
Sutton
Greenfield Park, Quebec
Mesa, Arizona
Woodbury, Minnesota
El Cajon, California
Durham, North Carolina
Seville
Fullerton, California
Anaheim, California
Lido di Camaiore
Arlington Heights, Illinois
Toledo, Ohio
Oceanside, California
Nashville, Tennessee
Detroit, Michigan
Glendale, California
Welwyn Garden City
Santa Ana, California
Bakersfield, California
Canton, Ohio
Glendale, Arizona
Thornton, Colorado
Gilly
Winston-Salem, North Carolina
Seetatarom
Aurora, Colorado
Rochester, New York
Koeln
Calgary, Alberta
Knoxville, Tennessee
Velbert
Bruxelles
Ogden, Utah
Lebanon, New Hampshire
Aberdeen
Austell, Georgia
Farmington, New Mexico
Kalispell, Montana
Milano
Southampton
Scottsdale, Arizona
Salem, Virginia
Wake Forest, North Carolina
Lynwood, California
Indianapolis, Indiana
Metairie, Louisiana
Springfield, Oregon
Redondo Beach, California
Hinsdale, Illinois
Kansas City, Missouri
Seongnam-si
New Haven, Connecticut
Hastings, Nebraska
Badajoz
Columbus, Ohio
Bronx, New York
Bristol
Roma
Huddersfield
Boston
Round Rock, Texas
Boca Raton, Florida
Plano, Texas
Seoul
Wirral
Roanoke, Virginia
Houston, Texas
Aschaffenburg
Cardiff
Chicago, Illinois
Manchester
South Australia
Gilbert, Arizona
Tainan
Bochum
Orange, California
Victoria
Wytheville, Virginia
Montebello, California
Arlington, Texas
Malaga
Chula Vista, California
Barcelona
Napoli
Birmingham
Torrance, California
Bedford, Texas
Sault Ste. Marie, Ontario
Auckland
Hudson, New York
Jonesboro, Arkansas
La Mesa, California
Bergamo
Middletown, Ohio
Laval, Quebec
Richmond, Virginia
Tucson, Arizona
Newnan, Georgia
Denver, Colorado
Ann Arbor, Michigan
Temple, Texas
Philadelphia, Pennsylvania
Johnson City, New York
Lancaster
Southington, Connecticut
New Orleans, Louisiana
Leuven
Oregon, Ohio
Cedar Park, Texas
Ashland, Kentucky
Frankford
Edegem
Madrid
Toronto, Ontario
Denton, Texas

Tracking Information

NCT #
NCT02117479
Collaborators
Not Provided
Investigators
Study Director: Fitzroy Dawkins, M.D. Incyte Corporation