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Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Incyte Corporation Identifier:
First received: August 22, 2011
Last updated: July 19, 2016
Last verified: July 2016
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 Intervention Phase
Metastatic Pancreatic Adenocarcinoma
Drug: Capecitabine
Drug: Ruxolitinib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Overall survival was measured as the length of time (in days) between the randomization date and the date of death.

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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

  • Objective Response Rate [ Time Frame: Measured every 4 weeks for duration of study treatment (up to 8 months) ] [ Designated as safety issue: No ]
    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.

  • Durable Response Rate [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ] [ Designated as safety issue: No ]
    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.

  • Summary of Clinical Benefit [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ] [ Designated as safety issue: No ]

    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.

Enrollment: 136
Study Start Date: July 2011
Estimated Study Completion Date: October 2016
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01423604

  Show 39 Study Locations
Sponsors and Collaborators
Incyte Corporation
Study Director: William Williams, MD Incyte Corporation
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Incyte Corporation Identifier: NCT01423604     History of Changes
Other Study ID Numbers: 18424-262 
Study First Received: August 22, 2011
Results First Received: April 1, 2016
Last Updated: July 19, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Metastatic pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on October 21, 2016