Status:
TERMINATED
An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel administered to patients with advanced or metastatic pancreatic cancer. The study will be conducted in two...
Eligibility Criteria
Inclusion
- Male or female, 18 years or older
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Requirements for prior therapy as outlined below:
- Enrollment into Regimen A: received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
- Enrollment into Regimen B: received no prior chemotherapy for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
- Adequate renal, hepatic, and bone marrow function without blood product or hematopoietic growth factor support:
- Able to swallow and retain oral medication
Exclusion
- Any known contraindications to the use of gemcitabine (for enrollment in Regimen A or B) or nab-paclitaxel (for enrollment into Regimen B).
- Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
- Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment. Subjects who have received radiation to the spine, pelvis, ribs, or femur should be discussed with the sponsor, as extensive radiation to marrow forming region may compromise a subject's ability to tolerate myelosuppressive chemotherapy. Subjects who have ongoing radiotherapy-related toxicities are not eligible.
- Subjects who participated in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
- Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or other noninvasive malignancy without sponsor approval.
- Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications.
- Recent (≤ 3 months) history of partial or complete bowel obstruction.
- Unwilling to be transfused with blood components.
- Known history of Hepatitis B or C infection or HIV infection.
- Presence of ≥ Grade 2 neuropathy
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01822756
Start Date
April 1 2013
End Date
August 1 2016
Last Update
February 12 2018
Active Locations (5)
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1
Birmingham, Alabama, United States
2
Gainesville, Florida, United States
3
Sarasota, Florida, United States
4
Durham, North Carolina, United States