BAY86-9766 combined with gemcitabine in advanced pancreatic cancer

• Research type

  Research Study

• Full title

  A multi-center, phase I/II study of BAY 86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer.

• IRAS ID

  66745

• Contact name

  Paul Ross

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2010-019588-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Open label, uncontrolled, Phase I/II Study to evaluate safety and efficacy of BAY 86-9766 plus gemcitabine, in locally advanced, unresectable or metastatic pancreatic cancer. Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY 86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended Phase II dose. Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability. Tumour assessments at Screening and then every 8 weeks. Safety evaluations at Screening and weekly throughout the study. Safety follow-up visit 30 days after the last dose of study treatment. Survival follow-up until death.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/SC/0044

• Date of REC Opinion

  21 Mar 2011

• REC opinion

  Favourable Opinion