Clinical trial NCT01423604: Study of Ruxolitinib in Pancreatic Cancer Patients
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 combination in this patient population.

A randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug).

Treatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.

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

Primary outcomes:
measure: Overall Survival
timeFrame: Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.
measure: Objective Response Rate
timeFrame: Measured every 4 weeks for duration of study treatment (up to 8 months)
measure: Durable Response Rate
timeFrame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
measure: Summary of Clinical Benefit
timeFrame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Burbank
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Arlington Heights
country: United States
state: Illinois
city: Elks Grove Village
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Sioux City
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Novi
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Voorhees
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Lake Success
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Danville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Green Bay
country: United States
state: Wisconsin
Study officials:
affiliation: Incyte Corporation
name: William Williams, MD
role: STUDY_DIRECTOR
References:
citation: Hurwitz HI, Uppal N, Wagner SA, Bendell JC, Beck JT, Wade SM 3rd, Nemunaitis JJ, Stella PJ, Pipas JM, Wainberg ZA, Manges R, Garrett WM, Hunter DS, Clark J, Leopold L, Sandor V, Levy RS. Randomized, Double-Blind, Phase II Study of Ruxolitinib or Placebo in Combination With Capecitabine in Patients With Metastatic Pancreatic Cancer for Whom Therapy With Gemcitabine Has Failed. J Clin Oncol. 2015 Dec 1;33(34):4039-47. doi: 10.1200/JCO.2015.61.4578. Epub 2015 Sep 8.