Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01423604
First received: August 22, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether ruxolitinib added to capecitabine are 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: Randomization through discontinuation or death (approximately over the course of five months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate efficacy of ruxolitinib treatment in combination with capecitabine based on tumor response rate [ Time Frame: Measured approximately every 3 weeks from baseline through study discontinuation (approximately over the course of five months) ] [ Designated as safety issue: No ]
  • Evaluate efficacy of ruxolitinib in combination with capecitabine for patient reported quality of life [ Time Frame: Measured approximately every 3 weeks from baseline through study discontinuation (approximately over the course of five months) ] [ Designated as safety issue: No ]
  • Evaluate efficacy of ruxolitinib treatment in combination with capecitabine for pain status [ Time Frame: Measured approximately every 3 weeks from baseline through study discontinuation (approximately over the course of five months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 138
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: October 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 or 1000mg/m^2 twice a day (NOTE: Frequency of administration may be increased during the study.)
Drug: Ruxolitinib
Ruxolitinib starting dose - 15mg BID (NOTE: Starting dose of randomized study may be 10mg 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 or 1000mg/m^2 twice a day (NOTE: Frequency of administration may be increased during the study.)
Drug: Placebo
Placebo matching ruxolitinib

Detailed Description:

The study consists of an open-label, safety run-in period which is comprised of 1 or 2 patient cohorts with ~ 9 patients/cohort. This phase of the study will determine the safety of the capecitabine/ruxolitinib combination in this patient population.

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of metastatic pancreatic cancer; subjects must have measurable, or evaluable disease that is histologically confirmed
  • Karnofsky performance status of ≥ 60
  • Subjects must have failed 1st line gemcitabine treatment for metastatic pancreatic cancer:

    • An alternate chemotherapeutic agent is 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 be 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 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 precludes 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 ClinicalTrials.gov identifier: NCT01423604

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

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01423604     History of Changes
Other Study ID Numbers: 18424-262
Study First Received: August 22, 2011
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Metastatic pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014