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Pancreatic CancerPhase 2RECAPNCT01423604

Study of Ruxolitinib in Pancreatic Cancer Patients

A Phase 2 study testing Capecitabine and Ruxolitinib in people with Pancreatic Cancer, run by Incyte Corporation at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Capecitabine and Ruxolitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
39 sitesUnited States
Study dates
Jul 2011to Nov 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington Heights, Illinois

  • Study site

    Bend, Oregon

  • Study site

    Birmingham, Alabama

  • Study site

    Boynton Beach, Florida

  • Study site

    Burbank, California

  • Study site

    Canton, Ohio

  • Study site

    Danville, Pennsylvania

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Elks Grove Village, Illinois

  • Study site

    Fort Myers, Florida

  • Study site

    Grand Rapids, Michigan

  • Study site

    Green Bay, Wisconsin

  • Study site

    Hickory, North Carolina

  • Study site

    Hot Springs, Arkansas

  • Study site

    Indianapolis, Indiana

  • Study site

    Knoxville, Tennessee

  • Study site

    Lake Success, New York

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Minneapolis, Minnesota

  • Study site

    Novi, Michigan

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Richmond, Virginia

  • Study site

    San Antonio, Texas

  • Study site

    Santa Monica, California

  • Study site

    Sioux City, Iowa

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stamford, Connecticut

  • Study site

    Tulsa, Oklahoma

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Worcester, Massachusetts

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
Capecitabine, Ruxolitinib, Placebo
Keywords
Metastatic pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    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.)

  • RuxolitinibDrug

    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.)

  • PlaceboDrug

    Placebo matching ruxolitinib

Study groups in NCT01423604
Study groupRoleWhat they receive
Capecitabine and ruxolitinibExperimentalNot described
Receives: Drug: Capecitabine; Drug: Ruxolitinib
Capecitabine and placeboPlacebo comparatorNot described
Receives: Drug: Capecitabine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival was measured as the length of time (in days) between the randomization date and the date of death.

    Measured: 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)

  1. 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

    Measured: 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.

  2. 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.

    Measured: Measured every 4 weeks for duration of study treatment (up to 8 months)

  3. 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.

    Measured: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)

  4. Summary of Clinical Benefit

    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.

    Measured: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2013
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01423604
Sponsor's protocol ID
18424-262
Acronym
RECAP
Status last verified
Jan 2018
First submitted
22 Aug 2011
Last updated
12 Feb 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26351344

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Ruxolitinib in people with Pancreatic Cancer, run by Incyte Corporation at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01423604, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.

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