Phase II PI3K inhibitor in relapsed, indolent or aggressive NHL

• Research type

  Research Study

• Full title

  Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas

• IRAS ID

  111702

• Contact name

  Kim Linton

• Sponsor organisation

  Bayer Plc

• Eudract number

  2012-002602-52

• Duration of Study in the UK

  3 years, 5 months, 30 days

• Research summary

  The objective of this study is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin’s Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease groups. Further objectives are to evaluate the pharmacokinetics and biomarkers.
  After an up to 14-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg.
  Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment and a safety follow-up visit will take place 30 – 35 days after the last administration of study treatment. Safety evaluations will be done at Screening, at each clinic visit during treatment and at the safety follow-up visit. All patients will be followed up for overall survival at 3-monthly intervals up to 3 years.
  The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic and biomarker analysis.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0618

• Date of REC Opinion

  19 Oct 2012

• REC opinion

  Further Information Favourable Opinion