Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer

Stopped early · Phase 2

Conditions studied: Metastatic Pancreatic Cancer

In brief

To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects with previously untreated metastatic pancreatic cancer using standard response criteria

Key facts

Study ID

NCT02570711

Run by

Acerta Pharma BV

People needed

3

Starts

2015-10-13

Expected to finish

2016-04-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 years of age.
• 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.

You may not qualify if…

• Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years.
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.