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TPS474 : A phase I safety and pharmacokinetic (PK) study of nab-paclitaxel (nab-P) plus gemcitabine (Gem) for patients (pts) with advanced pancreatic cancer (APC) who have cholestatic hyperbilirubinemia (CH) secondary to bile duct obstruction.

Researchers

Presenter

  • Hanno Riess

Principal Investigators

  • Volker Kunzmann

  • Philip Agop Philip

  • Thomas Seufferlein

  • Desmond Micahel Thomas McGovern

  • Peng Chen

  • Alfredo Romano

  • Ramesh K. Ramanathan

Medical Centers

  • Internistischen Onkologie/Campus Virchow-Klinikum, Charite-Universitaetsmedizin, Berlin, Germany

  • Karmanos Cancer Institute, Detroit, MI

  • Universitatsklinikum Ulm, Klinik fur Innere Medizin I, Ulm, Ulm, Germany

  • Celgene Europe Limited, Uxbridge, United Kingdom

  • Celgene, Berkeley Heights, NJ

  • Celgene International Sarl, Boudry, Switzerland

  • Mayo Clinic, Scottsdale, AZ

Locations

  • Germany

  • United States

  • United Kingdom

  • Switzerland

Companies

  • Celgene Europe Limit

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Gastroenterology (GU)

  • Cardiovascular (CVS)

Disease

  • Myocardial infarction

  • Hyperbilirubinemia

  • Pancreatic cancer

  • Brain metastasis

  • Solid malignancies

Biomarkers

  • Adenomatous Polyposis Coli

  • Carbohydrate antigen 19-9

  • Cytochrome P450 Family 3 Subfamily A Member 4

Drug/Treatment

  • Gemcitabine

  • Paclitaxel

Outcome

  • N/A


Study Design

  • Pharmacokinetics

  • Cohort

Phase

  • I

Study Id's

  • NCT02267707

Sponsors

  • N/A

Result

  • N/A