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)
18 Years
N/A
Both
Metastatic Pancreatic Adenocarcinoma
Trial Information
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)
The study consists of an open-label, safety run-in period which is comprised of 1 or 2
patient cohorts with ~ 9 patients/cohort. This phase of the study will determine the safety
of the capecitabine/ruxolitinib combination in this patient population.
A randomized, double-blind study with two treatment arms will be conducted following the
safety run-in if the results from the first part of the study show that the
capecitabine/ruxolitinib combination was safe and additional patients can be treated. All
patients will receive capecitabine therapy in addition to the ruxolitinib or placebo (Study
Drug).
Treatment for all patients will consist of repeating 21 day cycles. Capecitabine will be
self-administered for the first 14 days of each cycle and the Study Drug will be
self-administered during the entire 21 day cycle. Treatment cycles will continue as long as
the regimen is tolerated and the patient does not meet any of the discontinuation criteria.
In the event of disease progression, capecitabine therapy will be discontinued but the Study
Drug will continue to administered. Subjects who discontinue treatment with the Study Drug
will continue to be followed to obtain for subsequent treatment regimens and survival.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
Randomization through discontinuation or death (approximately over the course of five months)
Safety Issue:
No
Principal Investigator
Bijoyesh Mookerjee, MD
Investigator Role:
Study Director
Investigator Affiliation:
Incyte Corporation
Authority:
United States: Food and Drug Administration
Study ID:
18424-262
NCT ID:
NCT01423604
Start Date:
August 2011
Completion Date:
December 2013
Related Keywords:
- Metastatic Pancreatic Adenocarcinoma
- Metastatic pancreatic cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Bettendorf, Iowa 52722 | |
| Alexandria, Minnesota 56308 | |
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Denver, Colorado | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Tulsa, Oklahoma |
