Study of Ruxolitinib in Pancreatic Cancer Patients
RECAP
A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)
1 other identifier
interventional
136
1 country
39
Brief Summary
The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Jul 2011
Typical duration for phase_2 pancreatic-cancer
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedResults Posted
Study results publicly available
August 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 12, 2018
January 1, 2018
1.9 years
August 22, 2011
April 1, 2016
January 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival was measured as the length of time (in days) between the randomization date and the date of death.
Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).
Secondary Outcomes (4)
Progression-Free Survival (PFS)
Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.
Objective Response Rate
Measured every 4 weeks for duration of study treatment (up to 8 months)
Durable Response Rate
Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
Summary of Clinical Benefit
Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
Study Arms (2)
Capecitabine and ruxolitinib
EXPERIMENTALCapecitabine and placebo
PLACEBO COMPARATORInterventions
Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.)
Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.)
Eligibility Criteria
You may qualify if:
- years of age or older
- Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed
- Karnofsky performance status of ≥ 60
- Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer:
- o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine
- ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities
You may not qualify if:
- More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease
- Evidence of central nervous system (CNS) metastases (unless stable for \> 3 months) or history of uncontrolled seizures
- Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment
- Other active malignancy except basal or squamous carcinoma of the skin
- Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications
- Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Burbank, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Stamford, Connecticut, United States
Unknown Facility
Boynton Beach, Florida, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Arlington Heights, Illinois, United States
Unknown Facility
Elks Grove Village, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Sioux City, Iowa, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
Novi, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Voorhees Township, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Lake Success, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Hickory, North Carolina, United States
Unknown Facility
Canton, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Bend, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Danville, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Green Bay, Wisconsin, United States
Related Publications (1)
Hurwitz HI, Uppal N, Wagner SA, Bendell JC, Beck JT, Wade SM 3rd, Nemunaitis JJ, Stella PJ, Pipas JM, Wainberg ZA, Manges R, Garrett WM, Hunter DS, Clark J, Leopold L, Sandor V, Levy RS. Randomized, Double-Blind, Phase II Study of Ruxolitinib or Placebo in Combination With Capecitabine in Patients With Metastatic Pancreatic Cancer for Whom Therapy With Gemcitabine Has Failed. J Clin Oncol. 2015 Dec 1;33(34):4039-47. doi: 10.1200/JCO.2015.61.4578. Epub 2015 Sep 8.
PMID: 26351344DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
William Williams, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 26, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2013
Study Completion
November 1, 2016
Last Updated
February 12, 2018
Results First Posted
August 29, 2016
Record last verified: 2018-01