Recruitment

Recruitment Status
Terminated
Estimated Enrollment
310

Inclusion Criteria

Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Radiographically measurable or evaluable disease
...
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Radiographically measurable or evaluable disease
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
≥ 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.
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.

Exclusion Criteria

Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
Prior treatment with a JAK inhibitor for any indication.
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 treatment with a JAK inhibitor for any indication.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Received more than 1 prior regimen for advanced or metastatic disease.
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.

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 Criteria

Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Radiographically measurable or evaluable disease
...
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Radiographically measurable or evaluable disease
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
≥ 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.
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.

Exclusion Criteria

Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
Prior treatment with a JAK inhibitor for any indication.
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 treatment with a JAK inhibitor for any indication.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Received more than 1 prior regimen for advanced or metastatic disease.
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.

Locations

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

Tracking Information

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