Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
NCT ID: NCT02570711
Last Updated: 2019-08-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2015-10-13
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Regimen 1
ACP-196 and nab-paclitaxel and gemcitabine
ACP-196
ACP-196 capsule
Nab-paclitaxel
Nab-paclitaxel infusion
Gemcitabine
Gemcitabine infusion
Regimen 2
Nab-paclitaxel and gemcitabine
Nab-paclitaxel
Nab-paclitaxel infusion
Gemcitabine
Gemcitabine infusion
Interventions
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ACP-196
ACP-196 capsule
Nab-paclitaxel
Nab-paclitaxel infusion
Gemcitabine
Gemcitabine infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status of 0 or 1.
* Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
* No previous radiotherapy, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Exclusion Criteria
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with endobiliary stents may participate as long the enrollment criterion relating to serum bilirubin concentration is met.
* Breastfeeding or pregnant
18 Years
ALL
No
Sponsors
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Acerta Pharma BV
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Ventura Clinical Trials
Ventura, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Duke University Medical Center
Durham, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Tennessee Oncology
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
International Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ACE-ST-004
Identifier Type: -
Identifier Source: org_study_id
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