Study of Ruxolitinib in Colorectal Cancer Patients



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

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

A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

The purpose of this study was to determine if ruxolitinib, in combination with regorafenib,
is safe and effective in the treatment of metastatic colorectal cancer.

The study consisted of an open-label, Part 1 safety run-in (consisting of 1 to 3 cohorts of 9
subjects each), to confirm the safety of the regorafenib/ruxolitinib combination in subjects
with relapsed or refractory metastatic colorectal cancer (CRC). If determined to be
tolerable, Part 2 was to proceed as a randomized, double-blind study evaluating ruxolitinib
or placebo in combination with regorafenib in subjects with relapsed or refractory metastatic
CRC previously treated with fluoropyrimidine, oxaliplatin, and/or irinotecan based
chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy and if Kirsten rat
sarcoma (KRAS) wild type an anti-epidermal growth factor receptor (EGFR) therapy.

Subjects in the safety run-in received open-label ruxolitinib and regorafenib; for the
randomized, double-blind portion of the study all subjects received regorafenib and either
ruxolitinib or placebo in a 1:1 blinded manner. Treatment for all subjects consisted of
repeating 28-day cycles. Regorafenib was self-administered for the first 21 days of each
cycle, and ruxolitinib/placebo was self-administered during the entire 28-day cycle.
Treatment cycles continued as long as the regimen is tolerated, and the subject does not meet
the discontinuation criteria. When subjects discontinued regorafenib, ruxolitinib or placebo
they remained in the study and were followed for subsequent treatment regimens which were
initiated and survival.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that
is metastatic.

- Previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan- based
chemotherapy, an anti-VEGF therapy (if no contraindication) and if KRAS wild type and
no contraindication, an anti-EGFR therapy.

- Radiographically measurable or evaluable disease (per RECIST v1.1)

- Life expectancy of ≥ 12 weeks.

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

- Three or more weeks have elapsed from the completion of previous treatment regimen and
subjects must have recovered or be at a new stable baseline from any related
toxicities.

- Prior radiotherapy to disease sites is allowed with certain protocol-defined
restrictions.

Exclusion Criteria:

- Prior treatment with regorafenib.

- Presence of active gastrointestinal disease or other condition that will interfere
significantly with the absorption of drugs.

- Active peptic ulcer disease, inflammatory bowel disease (eg, ulcerative colitis,
Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased
risk of perforation or gastrointestinal bleeding.

- Recent history (≤ 3 months) or ongoing partial or complete bowel obstruction unless
due to disease under study and corrected with surgery.

- Blood pressure ≥ 140/90 mmHg.

- Active bleeding diathesis or history of any major bleeding (eg, requiring transfusion
of red blood cells (RBCs), central nervous system (CNS) bleeding, or significant
hemoptysis within 6 months of enrollment. Subjects with bleeding secondary to
underlying disease (including gastrointestinal (GI) perforation or fistula) that has
been corrected by surgery or alternative procedure may be included.

- Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within 6 months from Day 1 of study drug administration, New York Heart
Association Class II, III, or IV congestive heart failure, and arrhythmia requiring
therapy.
We found this trial at
58
sites
?
mi
from
Plano, TX
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
Altamonte Springs, Florida 32701
?
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
?
mi
from
American Fork, UT
Click here to add this to my saved trials
?
mi
from
Ames, IA
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bentleigh East,
Click here to add this to my saved trials
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Easley, SC
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Hudson, NY
Click here to add this to my saved trials
?
mi
from
Jefferson City, MO
Click here to add this to my saved trials
?
mi
from
Johnson City, NY
Click here to add this to my saved trials
?
mi
from
Lafayette, IN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Murray, UT
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Niles, IL
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Paris, TX
Click here to add this to my saved trials
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Provo, UT
Click here to add this to my saved trials
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Sumter, SC
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
?
mi
from
West Jordan, UT
Click here to add this to my saved trials