| General information |
| Database: | DB01088 |
| Objective: | Patients with advanced pancreatic adenocarcinoma have a poor prognosis and limited secondline treatment options. Evidence suggests a role for the Janus kinase (JAK)/signal transducer and activator of transcription pathway in the pathogenesis and clinical course of pancreatic cancer. |
| Authors: | Hurwitz HI, et al |
| Title: | Randomized, DoubleBlind, phase II Study of Ruxolitinib or Placebo in Combination With Capecitabine in Patients With Metastatic Pancreatic Cancer for Whom Therapy With Gemcitabine Has Failed. |
| Journal: | J Clin Oncol |
| Year: | 2015 |
| PMID: | 26351344 |
| Trial Design |
| Clinical Trial Id: | NCT01423604 |
| Agent: | Ruxolitinib
|
| Target: | Tyrosineprotein kinase JAK2
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Ruxolitinib+ Capecitabine |
| Study Type: | doubleblind, phase II study |
| Key Patients Feature: | patients with metastatic pancreatic cancer who had experienced treatment failure with gemcitabine |
| Biomarker: | serum Creactive protein levels |
| Biomark Analysis: | In a prespecified subgroup analysis of patients with inflammation, defined by serum Creactive protein levels greater than the study population median (ie, 13 mg/L), OS was significantly greater with ruxolitinib than with placebo (hazard ratio, 0.47; 95% CI, 0.26 to 0.85; P = .011) |
| Control Group Info: | Placebo+ Capecitabine |
| Treatment Info: | pts were randomly assigned 1:1 to the JAK1/JAK2 inhibitor ruxolitinib (15 mg twice daily) plus capecitabine (1, 000 mg/m(2) twice daily) or placebo plus capecitabine |
| Primary End Point: | overall survival (OS); |
| Secondary End Point: | progression free survival, clinical benefit response, objective response rate, and safety. |
| Patients Number: | 127 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | OR: 0.75 (95% CI, 0.52 to 1.10; P = .14) |
| Median OS A vs. C: | OR: 0.79 (95% CI, 0.53 to 1.18; P = .25) |
| Adverse Event(agent arm): | Grade 3 or greater adverse events were observed with similar frequency in the ruxolitinib (74.6%) and placebo (81.7%) groups. Grade 3 or greater anemia was more frequent with ruxolitinib (15.3%; placebo, 1.7%). |
| Conclusions: | Ruxolitinib plus capecitabine was generally well tolerated and may improve survival in patients with metastatic pancreatic cancer and evidence of systemic inflammation. |