Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma (NCT02921022) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma
United States110 participantsStarted 2016-10
Plain-language summary
The purpose of this study is to test any good and bad effects of the study drug called PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA) has not approved the marketing or sale of PEGPH20, but have authorized its use in research studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects. PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of hyaluronan from tumors may decrease tumor growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
* Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC.
* Measurable or evaluable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
* For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted. For patients with metastatic disease, prior treatment for non-metastatic disease with 5-FU or gemictabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ≥ Grade 2 treatment-related toxicities are present.
* Karnofsky Performance Status ≥70%.
* Life expectancy ≥3 months.
* Age ≥18 years.
* A negative serum pregnancy test, if female of reproductive potential.
* Screening clinical laboratory values as follows, performed within 14 days prior to day 1:
* Total bilirubin ≤1.5 times upper limit of normal (ULN).
* Aspartate aminotransferase (\[AST\]; serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (\[ALT\]; serum glutamic pyruvate transaminase \[SGPT\]) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).
* Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min.
* Serum albumin ≥3.0 g/dL.
* Abs…