Overview

This trial is active, not recruiting.

Condition metastatic pancreatic adenocarcinoma
Treatments capecitabine, ruxolitinib, placebo
Phase phase 2
Target JAK
Sponsor Incyte Corporation
Start date August 2011
End date October 2013
Trial size 138 participants
Trial identifier NCT01423604, 18424-262

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
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.)
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
Capecitabine starting dose - 2000 mg/m^2 or 1000mg/m^2 twice a day (NOTE: Frequency of administration may be increased during the study.)
placebo
Placebo matching ruxolitinib

Primary Outcomes

Measure
Overall survival
time frame: Randomization through discontinuation or death (approximately over the course of five months)

Secondary Outcomes

Measure
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)
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)
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Incyte Corporation.