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Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Pancreatic Adenocarcinoma

Intervention: Ruxolitinib (Drug); Placebo (Drug); Capecitabine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Incyte Corporation

Official(s) and/or principal investigator(s):
Fitzroy Dawkins, M.D., Study Director, Affiliation: Incyte Corporation

Overall contact:
Incyte Corporation Call Center, Phone: 844-23JANUS

Summary

To determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

Clinical Details

Official title: A Randomized, Double-Blind, Phase 3 Study of the Janus Kinase (JAK) 1/2 Inhibitor, Ruxolitinib, or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Overall Survival (OS)

Secondary outcome:

Progression-free survival (PFS)

Objective Response Rate (ORR)

Duration of Response

Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.

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

- Treatment A (N = 155): Capecitabine + ruxolitinib

- Treatment B (N = 155): Capecitabine + placebo

Treatment will consist of repeating 21-day cycles. Capecitabine will be self-administered for the first 14 days of each cycle, and ruxolitinib/placebo will be self-administered during the entire cycle. Treatment for all subjects will continue as long as the regimen is tolerated, and the subject does not meet discontinuation criteria. Subjects who discontinue treatment will continue to be followed for subsequent anticancer treatments and survival.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas.

- Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- Received 1 prior chemotherapy regimen for advanced or metastatic disease (not

including neoadjuvant and/or adjuvant therapy).

- ≥ 2 weeks elapsed from the completion of previous treatment regimen and subjects 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:

- C-reactive protein >10 mg/L AND albumin ≥35 g/L; Score = 1

- C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2

Exclusion Criteria:

- Received more than 1 prior regimen for advanced or metastatic disease.

- Ongoing radiation therapy, radiation therapy administered within 30 days of

enrollment.

- Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery,

immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).

- 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.

- Prior treatment with a JAK inhibitor for any indication.

Locations and Contacts

Incyte Corporation Call Center, Phone: 844-23JANUS

Australian Capital Territory, Australia; Recruiting

New South Wales, Australia; Recruiting

South Australia, Australia; Recruiting

Victoria, Australia; Recruiting

Aalst, Belgium; Recruiting

Brugge, Belgium; Recruiting

Bruxelles, Belgium; Recruiting

Edegem, Belgium; Recruiting

Gent, Belgium; Recruiting

Gilly, Belgium; Recruiting

Kortrijk, Belgium; Recruiting

Leuven, Belgium; Recruiting

Aschaffenburg, Germany; Recruiting

Berlin, Germany; Recruiting

Bochum, Germany; Recruiting

Essen, Germany; Recruiting

Frankford, Germany; Recruiting

Koeln, Germany; Recruiting

Velbert, Germany; Recruiting

Aviano, Italy; Recruiting

Bari, Italy; Recruiting

Bergamo, Italy; Recruiting

Brescia, Italy; Recruiting

Cremona, Italy; Recruiting

Firenze, Italy; Recruiting

Genova, Italy; Recruiting

Lido di Camaiore, Italy; Recruiting

Milano, Italy; Recruiting

Napoli, Italy; Recruiting

Pisa, Italy; Recruiting

Rimini, Italy; Recruiting

Roma, Italy; Recruiting

Hwasun-gun, Korea, Republic of; Recruiting

Seongnam-si, Korea, Republic of; Recruiting

Seoul, Korea, Republic of; Recruiting

Auckland, New Zealand; Recruiting

Christchurch, New Zealand; Recruiting

Hamilton, New Zealand; Recruiting

Badajoz, Spain; Recruiting

Barcelona, Spain; Recruiting

Madrid, Spain; Recruiting

Malaga, Spain; Recruiting

Seville, Spain; Recruiting

Taichung, Taiwan; Recruiting

Tainan, Taiwan; Recruiting

Taipei, Taiwan; Recruiting

Patumwan, Thailand; Recruiting

Ratchathewi, Thailand; Recruiting

Seetatarom, Thailand; Recruiting

Aberdeen, United Kingdom; Recruiting

Bangor, United Kingdom; Recruiting

Birmingham, United Kingdom; Recruiting

Boston, United Kingdom; Recruiting

Bristol, United Kingdom; Recruiting

Cardiff, United Kingdom; Recruiting

Glasgow, United Kingdom; Recruiting

Guildford, United Kingdom; Recruiting

Harlow, United Kingdom; Recruiting

Huddersfield, United Kingdom; Recruiting

Lancaster, United Kingdom; Recruiting

Leeds, United Kingdom; Recruiting

London, United Kingdom; Recruiting

Manchester, United Kingdom; Recruiting

Newcastle upon Tyne, United Kingdom; Recruiting

Nottingham, United Kingdom; Recruiting

Plymouth, United Kingdom; Recruiting

Southampton, United Kingdom; Recruiting

Sutton, United Kingdom; Recruiting

Welwyn Garden City, United Kingdom; Recruiting

Wirral, United Kingdom; Recruiting

Calgary, Alberta, Canada; Recruiting

Chandler, Arizona, United States; Recruiting

Glendale, Arizona, United States; Recruiting

Hot Springs, Arizona, United States; Recruiting

Jonesboro, Arizona, United States; Recruiting

Phoenix, Arizona, United States; Recruiting

Tucson, Arizona, United States; Recruiting

Bakersfield, California, United States; Recruiting

Berkeley, California, United States; Recruiting

El Cajon, California, United States; Recruiting

Fullerton, California, United States; Recruiting

Gilroy, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Modesto, California, United States; Recruiting

Northridge, California, United States; Recruiting

Oceanside, California, United States; Recruiting

Redondo Beach, California, United States; Recruiting

San Diego, California, United States; Recruiting

San Francisco, California, United States; Recruiting

San Luis Obispo, California, United States; Recruiting

Santa Maria, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Whittier, California, United States; Recruiting

Denver, Colorado, United States; Recruiting

Grand Junction, Colorado, United States; Recruiting

Southington, Connecticut, United States; Recruiting

Trumbull, Connecticut, United States; Recruiting

Newark, Delaware, United States; Recruiting

Boca Raton, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

Pembroke Pines, Florida, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Marietta, Georgia, United States; Recruiting

Newnan, Georgia, United States; Recruiting

Rome, Georgia, United States; Recruiting

Arlington Heights, Illinois, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Urbana, Illinois, United States; Recruiting

Goshen, Indiana, United States; Recruiting

Topeka, Kansas, United States; Recruiting

Ashland, Kentucky, United States; Recruiting

Marrero, Louisiana, United States; Recruiting

Scarborough, Maine, United States; Recruiting

Annapolis, Maryland, United States; Recruiting

Bethesda, Maryland, United States; Recruiting

Rockville, Maryland, United States; Recruiting

Worcester, Massachusetts, United States; Recruiting

Ann Arbor, Michigan, United States; Recruiting

Detroit, Michigan, United States; Recruiting

Woodbury, Minnesota, United States; Recruiting

Kansas City, Missouri, United States; Recruiting

St. Louis, Missouri, United States; Recruiting

Hastings, Nebraska, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

Farmington, New Mexico, United States; Recruiting

Birmingham, New York, United States; Recruiting

Bronx, New York, United States; Recruiting

Hudson, New York, United States; Recruiting

New York, New York, United States; Recruiting

Nyack, New York, United States; Recruiting

Durham, North Carolina, United States; Recruiting

Wake Forest, North Carolina, United States; Recruiting

Winston-Salem, North Carolina, United States; Recruiting

Columbus, Ohio, United States; Recruiting

Middletown, Ohio, United States; Recruiting

Toledo, Ohio, United States; Recruiting

Oshawa, Ontario, Canada; Recruiting

Sault Ste. Marie, Ontario, Canada; Recruiting

Toronto, Ontario, Canada; Recruiting

Eugene, Oregon, United States; Recruiting

Portland, Oregon, United States; Recruiting

Greenfield Park, Quebec, Canada; Recruiting

Laval, Quebec, Canada; Recruiting

Montreal, Quebec, Canada; Recruiting

Charleston, South Carolina, United States; Recruiting

Spartanburg, South Carolina, United States; Recruiting

Knoxville, Tennessee, United States; Recruiting

Memphis, Tennessee, United States; Recruiting

Arlington, Texas, United States; Recruiting

Beaumont, Texas, United States; Recruiting

Bedford, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Denton, Texas, United States; Recruiting

El Paso, Texas, United States; Recruiting

Fort Worth, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Plano, Texas, United States; Recruiting

Round Rock, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Waco, Texas, United States; Recruiting

Ogden, Utah, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Roanoke, Virginia, United States; Recruiting

Seattle, Washington, United States; Recruiting

Madison, Wisconsin, United States; Recruiting

Additional Information

Starting date: March 2014
Last updated: July 30, 2015

Page last updated: August 23, 2015

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