Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Incyte

Status and phase

Terminated

Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: Placebo

Drug: Capecitabine

Drug: Ruxolitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02117479

INCB 18424-362

Details and patient eligibility

About

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

Full 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 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.

Enrollment

321 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
≥ 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.
Radiographically measurable or evaluable disease
Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
1. mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
2. mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L

Exclusion criteria

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 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.