A Study of Ruxolitinib in Pancreatic Cancer Patients

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which
approximately 270 participants with advanced or metastatic adenocarcinoma of the pancreas who
had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one
of the following treatment groups:

- Treatment A (N = 135): Capecitabine + ruxolitinib

- Treatment B (N = 135): 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 during the entire
cycle. Treatment for all participants was to continue as long as the regimen was tolerated,
and the participant did not meet discontinuation criteria. Participants who discontinued
treatment continued to be followed for subsequent anticancer treatments and survival.

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

- An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

- Criteria:

1. mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L

2. mGPS of 2: CRP > 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).

- Current or previous other malignancy within 2 years of study entry without sponsor
approval

- Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase
deficiency (DPD), or other known hypersensitivity to active substances, including
fluorouracil (5-FU), ruxolitinib, or any of their excipients.

- Prior treatment with a JAK inhibitor for any indication.