Study of Ruxolitinib in Pancreatic Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 29 October 2012
• Main ID: NCT01423604
• Date of registration: 22/08/2011
• Primary sponsor: Incyte Corporation
• Public title: Study of Ruxolitinib in Pancreatic Cancer Patients RECAP
• Scientific title: A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With CApecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)
• Date of first enrolment: August 2011
• Target sample size: 138
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01423604
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Incyte Corporation Call Center

• Name: Bijoyesh Mookerjee, MD
• Affiliation: Incyte Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years of age or older

- Diagnosis of metastatic pancreatic cancer; subjects must have measurable, or
evaluable disease that is histologically confirmed

- Karnofsky performance status of = 60

- Subjects must have failed 1st line gemcitabine treatment for metastatic pancreatic
cancer:

o An alternate chemotherapeutic agent is 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 be 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 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 precludes
administration of oral medications

- Inadequate renal, hepatic and bone marrow function demonstrated by clinical
observations and/or laboratory assessments



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Pancreatic Adenocarcinoma

Intervention(s)

Drug: Number 1 - Capecitabine and ruxolitinib

Drug: Number 2 - Capecitabine and placebo

Primary Outcome(s)

Overall survival [Time Frame: Randomization through discontinuation or death (approximately over the course of five months)]

Secondary Outcome(s)

Evaluate efficacy of ruxolitinib in combination with capecitabine for patient reported quality of life [Time Frame: Measured approximately every 3 weeks from baseline through study discontinuation (approximately over the course of five months)]

Evaluate efficacy of ruxolitinib treatment in combination with capecitabine based on tumor response rate [Time Frame: Measured approximately every 3 weeks from baseline through study discontinuation (approximately over the course of five months)]

Evaluate efficacy of ruxolitinib treatment in combination with capecitabine for pain status [Time Frame: Measured approximately every 3 weeks from baseline through study discontinuation (approximately over the course of five months)]

Secondary ID(s)

18424-262

Source(s) of Monetary Support

Please refer to primary and secondary sponsors