Source: https://www.smartpatients.com/trials/NCT01858883
Timestamp: 2017-01-19 06:35:01
Document Index: 67385896

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Safety Study of INCB039110 in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors | Smart Patients
metastatic cancer, metastatic pancreatic cancer
incb039110, gemcitabine, nab-paclitaxel, filgrastim
NCT01858883, INCB 39110-116
Test the hypothesis that INCB039110 can be administered safely in combination with
gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
Fayetteville, AR not available
Southington, CT not available
Safety and tolerability of combination therapy study treatment INCB039110 plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
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 INCB039110 in the treatment regimens administered
Each cohort will be observed for a minimum of 28 days.
Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent INCB039110
Baseline up to 6 months.
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).
- Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic
adenocarcinoma (Part 2)
- 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
- 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)
- Any known contraindications to the use of a required comedication (gemcitabine or
nab-paclitaxel).
- Ongoing radiation therapy and/or radiation therapy administered within 28 days of
enrollment or ongoing radiotherapy-related toxicities.
- Inability to swallow food or any condition of the upper GI tract that precludes
Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that
includes identifying the MTD of 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 INCB039110 when administered in combination with gemcitabine and nab-paclitaxel in
subjects with untreated advanced or metastatic pancreatic cancer.