A Study of Ruxolitinib in Pancreatic Cancer Patients



Status:Terminated
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/15/2018
Start Date:June 2014
End Date:October 2016

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Phase 3 Study of the 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 2 Study)

This was to determine the efficacy, based upon overall survival, of ruxolitinib added to
capecitabine for the treatment of metastatic pancreatic cancer.

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which
approximately 270 participants with advanced or metastatic adenocarcinoma of the pancreas who
had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one
of the following treatment groups:

- Treatment A (N = 135): Capecitabine + ruxolitinib

- Treatment B (N = 135): 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 during the entire
cycle. Treatment for all participants was to continue as long as the regimen was tolerated,
and the participant did not meet discontinuation criteria. Participants who discontinued
treatment continued to be followed for subsequent anticancer treatments and survival.

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 participants
must have recovered or be at a new stable baseline from any related toxicities.

- Radiographically measurable or evaluable disease

- An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

- Criteria:

1. mGPS of 1: C-reactive protein (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 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).

- Current or previous other malignancy within 2 years of study entry without sponsor
approval

- Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase
deficiency (DPD), or other known hypersensitivity to active substances, including
fluorouracil (5-FU), ruxolitinib, or any of their excipients.

- Prior treatment with a JAK inhibitor for any indication.
We found this trial at
56
sites
1302
mi
from
Harrison, NY
Click here to add this to my saved trials
1209
mi
from
Allentown, PA
Click here to add this to my saved trials
844
mi
from
Athens, GA
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
402
mi
from
Aurora, CO
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
Basking Ridge, New Jersey 07920
1258
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
241
mi
from
Bolivar, MO
Click here to add this to my saved trials
1444
mi
from
Boston, MA
Click here to add this to my saved trials
900
mi
from
Canton, OH
Click here to add this to my saved trials
719
mi
from
Chattanooga, TN
Click here to add this to my saved trials
1232
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
1324
mi
from
Commack, NY
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
409
mi
from
Denver, CO
Click here to add this to my saved trials
1118
mi
from
Falls Church, VA
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
829
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
234
mi
from
Fayetteville, AR
Click here to add this to my saved trials
1205
mi
from
Fort Myers, FL
Click here to add this to my saved trials
346
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1297
mi
from
Fresh Meadows, NY
Click here to add this to my saved trials
503
mi
from
Graz,
Click here to add this to my saved trials
689
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greenville, South Carolina 29605
882
mi
from
Greenville, SC
Click here to add this to my saved trials
601
mi
from
Harvey, IL
Click here to add this to my saved trials
1147
mi
from
Hershey, PA
Click here to add this to my saved trials
660
mi
from
Huntsville, AL
Click here to add this to my saved trials
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
721
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
196
mi
from
Kansas City, KS
Click here to add this to my saved trials
779
mi
from
Knoxville, TN
Click here to add this to my saved trials
1118
mi
from
La Jolla, CA
Click here to add this to my saved trials
1238
mi
from
Langhorne, PA
Click here to add this to my saved trials
779
mi
from
Lansing, MI
Click here to add this to my saved trials
657
mi
from
Louisville, KY
Click here to add this to my saved trials
368
mi
from
Lubbock, TX
Click here to add this to my saved trials
871
mi
from
Macon, GA
Click here to add this to my saved trials
552
mi
from
Minneapolis, MN
Click here to add this to my saved trials
618
mi
from
Nashville, TN
Click here to add this to my saved trials
1290
mi
from
New York, NY
Click here to add this to my saved trials
1170
mi
from
Newport News, VA
Click here to add this to my saved trials
1383
mi
from
Portland, OR
Click here to add this to my saved trials
1122
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
1305
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
548
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
1117
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
583
mi
from
San Antonio, TX
Click here to add this to my saved trials
1410
mi
from
Seattle, WA
Click here to add this to my saved trials
1295
mi
from
Sleepy Hollow, NY
Click here to add this to my saved trials
460
mi
from
Temple, TX
Click here to add this to my saved trials
921
mi
from
Thomasville, GA
Click here to add this to my saved trials
1234
mi
from
Voorhees, NJ
Click here to add this to my saved trials
1127
mi
from
Washington,
Click here to add this to my saved trials