An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors
This trial is active, not recruiting.
|Conditions||metastatic cancer, metastatic pancreatic cancer|
|Treatments||ruxolitinib, gemcitabine, nab-paclitaxel, filgrastim|
|Targets||JAK, JAK1, JAK2|
|Start date||April 2013|
|End date||September 2015|
|Trial size||75 participants|
|Trial identifier||NCT01822756, INCB 18424-144|
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 parts.
Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of ruxolitinib when given as described to patients with advanced or metastatic pancreatic cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be selected for use in Part 2 of the study.
Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic pancreatic cancer.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Birmingham, AL||not available||no longer recruiting|
|Gainesville, FL||not available||no longer recruiting|
|Sarasota, FL||not available||no longer recruiting|
|Durham, NC||not available||no longer recruiting|
|Nashville, TN||not available||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Adverse events that are defined as dose limiting toxicities occurring in the first 28 days of treatment.
time frame: Approximately 28 days
Plasma concentrations will be used to estimate peak plasma concentration (cmax) and area under the plasma concentration curve (AUC).
time frame: Day 1 and Day 8
Plasma concentration of tumor specific biomarkers and cytokines before and during treatment.
time frame: Up to 6 months
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
time frame: Approximately 6 months
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||A Phase 1b Study of the Safety and Tolerability of Ruxolitinib in Combination With Gemcitabine With or Without Nab-Paclitaxel in Subjects With Advanced Solid Tumors|
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