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Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)

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ClinicalTrials.gov Identifier: NCT01423604
Recruitment Status : Completed
First Posted : August 26, 2011
Results First Posted : August 29, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Capecitabine Drug: Ruxolitinib Drug: Placebo Phase 2

Detailed Description:

The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population.

A randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug).

Treatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Capecitabine and ruxolitinib Drug: Capecitabine
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.)

Drug: Ruxolitinib
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.)
Placebo Comparator: Capecitabine and placebo Drug: Capecitabine
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.)

Drug: Placebo
Placebo matching ruxolitinib


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 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). ]
    Overall survival was measured as the length of time (in days) between the randomization date and the date of death.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 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. ]
    Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  2. Objective Response Rate [ Time Frame: Measured every 4 weeks for duration of study treatment (up to 8 months) ]
    Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  3. Durable Response Rate [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ]
    Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.

  4. Summary of Clinical Benefit [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ]

    A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:

    1. Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status
    2. Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423604


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Burbank, California, United States
Los Angeles, California, United States
Santa Monica, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Stamford, Connecticut, United States
United States, Florida
Boynton Beach, Florida, United States
Fort Myers, Florida, United States
Saint Petersburg, Florida, United States
United States, Illinois
Arlington Heights, Illinois, United States
Elks Grove Village, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Sioux City, Iowa, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Novi, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New Jersey
Voorhees, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Lake Success, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Hickory, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Dayton, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Oregon
Bend, Oregon, United States
Portland, Oregon, United States
United States, Pennsylvania
Danville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Richmond, Virginia, United States
United States, Wisconsin
Green Bay, Wisconsin, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: William Williams, MD Incyte Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01423604    
Other Study ID Numbers: 18424-262
First Posted: August 26, 2011    Key Record Dates
Results First Posted: August 29, 2016
Last Update Posted: February 12, 2018
Last Verified: January 2018
Keywords provided by Incyte Corporation:
Metastatic pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents