Recruitment

Recruitment Status
Terminated
Estimated Enrollment
310

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Radiographically measurable or evaluable disease
...
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Radiographically measurable or evaluable disease
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L

Exclusion Criteria

Received more than 1 prior regimen for advanced or metastatic disease.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
...
Received more than 1 prior regimen for advanced or metastatic disease.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
Prior treatment with a JAK inhibitor for any indication.
Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.

Summary

Conditions
Pancreatic Cancer
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment g...

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups: Treatment A (N = 155): Capecitabine + ruxolitinib Treatment B (N = 155): Capecitabine + placebo Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Radiographically measurable or evaluable disease
...
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Radiographically measurable or evaluable disease
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L

Exclusion Criteria

Received more than 1 prior regimen for advanced or metastatic disease.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
...
Received more than 1 prior regimen for advanced or metastatic disease.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
Prior treatment with a JAK inhibitor for any indication.
Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.

Tracking Information

NCT #
NCT02117479
Collaborators
Not Provided
Investigators
Study Director: Fitzroy Dawkins, M.D. Incyte Corporation
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