Study of Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Previously Untreated Metastatic Pancreatic Cancer
Status: | Terminated |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/25/2016 |
Start Date: | October 2015 |
To evaluate the Safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects
with metastatic pancreatic cancer using standard response criteria
with metastatic pancreatic cancer using standard response criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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