Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)
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Purpose
The purpose of this study is to determine whether ruxolitinib added to capecitabine are effective in improving the overall survival of patients with metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Pancreatic Adenocarcinoma |
Drug: Number 1 - Capecitabine and ruxolitinib Drug: Number 2 - Capecitabine and placebo |
Phase 2 |
| 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 |
| 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) |
- Overall survival [ Time Frame: Randomization through discontinuation or death (approximately over the course of five months) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 138 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Capecitabine and ruxolitinib |
Drug: Number 1 - Capecitabine and ruxolitinib
Capecitabine - Starting dose - 2000 mg/m2 or 1000mg/m2 twice a day (NOTE: Frequency of administration may be increased during the study.) Ruxolitinib - Starting dose - 15mg BID (NOTE: Starting dose of randomized study may be 10mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.) |
| Placebo Comparator: Capecitabine and placebo |
Drug: Number 2 - Capecitabine and placebo
Capecitabine - Starting dose - 2000 mg/m2 or 1000mg/m2 twice a day NOTE: Frequency of capecitabine administration may be increased during the study.) Placebo matching ruxolitinib |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 39 Study Locations| Study Director: | Bijoyesh Mookerjee, MD | Incyte Corporation |
More Information
No publications provided
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT01423604 History of Changes |
| Other Study ID Numbers: | 18424-262 |
| Study First Received: | August 22, 2011 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Incyte Corporation:
|
Metastatic pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases |
Endocrine System Diseases Capecitabine Fluorouracil Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013