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Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
Ruxolitinib
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Metastatic pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Capecitabine and ruxolitinib

Capecitabine and placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
August 22, 2011
Last Updated
January 15, 2018
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01423604
Brief Title
Study of Ruxolitinib in Pancreatic Cancer Patients
Acronym
RECAP
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Metastatic pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine and ruxolitinib
Arm Type
Experimental
Arm Title
Capecitabine and placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
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.)
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
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.)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching ruxolitinib
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was measured as the length of time (in days) between the randomization date and the date of death.
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).
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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
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.
Title
Objective Response Rate
Description
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.
Time Frame
Measured every 4 weeks for duration of study treatment (up to 8 months)
Title
Durable Response Rate
Description
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.
Time Frame
Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
Title
Summary of Clinical Benefit
Description
A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria: 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 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.
Time Frame
Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Williams, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
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United States
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Hot Springs
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Arkansas
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United States
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Burbank
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Los Angeles
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Santa Monica
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Denver
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Stamford
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Boynton Beach
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Fort Myers
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Saint Petersburg
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Arlington Heights
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Elks Grove Village
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Indianapolis
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Sioux City
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Lexington
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Louisville
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Worcester
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Ann Arbor
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Detroit
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Grand Rapids
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Novi
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Minneapolis
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Saint Louis
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Voorhees
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Albuquerque
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New Mexico
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Lake Success
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New York
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Durham
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Hickory
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Canton
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Ohio
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Dayton
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Tulsa
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Bend
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Portland
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Danville
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United States
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Pittsburgh
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Knoxville
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Tennessee
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United States
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San Antonio
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Texas
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United States
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Richmond
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Virginia
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United States
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Green Bay
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Wisconsin
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United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26351344
Citation
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.
Results Reference
derived

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Study of Ruxolitinib in Pancreatic Cancer Patients

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