Status:
COMPLETED
Study of Ruxolitinib in Pancreatic Cancer Patients
Lead Sponsor:
Incyte Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.
Detailed Description
The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib c...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed
- Karnofsky performance status of ≥ 60
- Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer:
- o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine
- ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities
Exclusion
- More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease
- Evidence of central nervous system (CNS) metastases (unless stable for \> 3 months) or history of uncontrolled seizures
- Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment
- Other active malignancy except basal or squamous carcinoma of the skin
- Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications
- Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT01423604
Start Date
July 1 2011
End Date
November 1 2016
Last Update
February 12 2018
Active Locations (39)
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1
Birmingham, Alabama, United States
2
Hot Springs, Arkansas, United States
3
Burbank, California, United States
4
Los Angeles, California, United States