Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT02117479

Run by

Incyte Corporation

People needed

321

Starts

2014-03-01

Expected to finish

2016-12-01

Last updated by the study team

2019-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
• mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L

You may not qualify if…

• 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.

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Gilbert, Arizona, United States
• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Surprise, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Bakersfield, California, United States
• Study site — Berkeley, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Chula Vista, California, United States
• Study site — Covina, California, United States
• Study site — Downey, California, United States
• Study site — El Cajon, California, United States
• Study site — Fullerton, California, United States
• Study site — Gilroy, California, United States
• Study site — Glendale, California, United States
• Study site — La Mesa, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Avondale, Arizona, United States

Full record on ClinicalTrials.gov

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