Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 310
Inclusion Criteria
- Radiographically measurable or evaluable disease
- mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
- Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
- ...
- Radiographically measurable or evaluable disease
- mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
- Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
- 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.
Exclusion Criteria
- 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.
- Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
- ...
- 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.
- Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
- Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
- Prior treatment with a JAK inhibitor for any indication.
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
- Radiographically measurable or evaluable disease
- mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
- Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
- ...
- Radiographically measurable or evaluable disease
- mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
- Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
- 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.
Exclusion Criteria
- 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.
- Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
- ...
- 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.
- Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
- Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
- Prior treatment with a JAK inhibitor for any indication.
Tracking Information
- NCT #
- NCT02117479
- Collaborators
- Not Provided
- Investigators
- Study Director: Fitzroy Dawkins, M.D. Incyte Corporation
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