Phase 2
Completed N=9
Study of Ruxolitinib in Pancreatic Cancer Patients
Source: ClinicalTrials.gov NCT01423604 ↗Enrolled (actual)
9
Serious AEs
56.3%
Results posted
Aug 2016
Primary outcomePrimary: Overall Survival — 136.5; 129.5 days — p=0.0494
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
136.5; 129.5 | 0.0494 sig |
| SECONDARY Progression-Free Survival (PFS) |
51.0; 46.0 | 0.1340 |
| SECONDARY Objective Response Rate |
7.8; 1.6; 1.6; 0.0; 6.3; 1.6 | — |
| SECONDARY Durable Response Rate |
7.8; 0.0 | 0.0236 sig |
| SECONDARY Summary of Clinical Benefit |
12.5; 1.6; 10.9; 1.6; 4.7; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01423604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.