A Study of Ruxolitinib in Pancreatic Cancer Patients

Incyte

Status and phase

Terminated

Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: Ruxolitinib

Drug: Placebo

Drug: Capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02119663

INCB 18424-363

Details and patient eligibility

About

This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

Full description

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.

Enrollment

86 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
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.