Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
This trial has been completed.
|Conditions||metastatic cancer, metastatic pancreatic cancer|
|Treatments||itacitinib, gemcitabine, nab-paclitaxel, filgrastim|
|Phase||phase 1/phase 2|
|Start date||June 2013|
|End date||February 2016|
|Trial size||55 participants|
|Trial identifier||NCT01858883, INCB 39110-116|
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsdale, AZ||not available||completed|
|Fayetteville, AR||not available||completed|
|Beverly Hills, CA||not available||completed|
|Southington, CT||not available||completed|
|Indianapolis, IN||not available||completed|
|Baltimore, MD||not available||completed|
|Baltimore, MD||Johns Hopkins University / Sidney Kimmel Cancer Center||no longer recruiting|
|Lake Success, NY||not available||completed|
|New York, NY||Laura and Isaac Perlmutter Cancer Center at NYU Langone||no longer recruiting|
|Philadelphia, PA||not available||completed|
|Philadelphia, PA||University of Pennsylvania / Abramson Cancer Center||no longer recruiting|
|Philadelphia, PA||Fox Chase Cancer Center||no longer recruiting|
|Intervention model||single group assignment|
Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
time frame: Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit (approximately 6 months).
Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered
time frame: Each cohort will be observed for a minimum of 28 days.
Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)
time frame: Baseline up to 6 months.
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
time frame: Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).
All participants at least 18 years old.
Inclusion Criteria: - Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic adenocarcinoma (Part 2) - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 - Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1) - Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a) - Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions > 2 units packed red blood cells every 3 months) - Ability to swallow and retain oral medication Exclusion Criteria: - Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel). - Evidence of uncontrolled brain metastases or history of uncontrolled seizures. - Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment or ongoing radiotherapy-related toxicities. - Presence of ≥ Grade 2 neuropathy. - 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. - Unwillingness to be transfused with blood components. - Known history of Hepatitis B or C infection or HIV infection
|Official title||Official Title: A Phase 1B/2 Study of the Safety and Tolerability of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors|
|Description||Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that includes identifying the MTD of itacitinib (INCB039110) (within a defined pharmacologic range) in combination with doses of gemcitabine and nab-paclitaxel that have established safety and tolerability in subjects with advanced or metastatic solid tumors. Study Part 2 and Part 2A: This phase will explore the safety and tolerability of the MTD or PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.|
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