A Cancer Research UK Phase I/IIa trial of MK-0752 with gemcitabine.

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I/IIa Trial of an Oral Notch inhibitor (MK-0752) in Combination with Gemcitabine in Patients with Stage IV Pancreatic Cancer

• IRAS ID

  40423

• Contact name

  Duncan Jodrell

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2008-004829-42

• ISRCTN Number

  NA

• Research summary

  This is a Cancer Research UK Phase I/IIa Trial of an Oral Notch Inhibitor (MK-0752) in combination with gemcitabine in patients with advanced (stage IV) pancreatic cancer. It is an open label, multi centre, non-randomised Bayesian Adaptive Phase I/IIa study. Approximately 60 patients with Stage IV pancreatic cancer will be entered into this study, which will have a duration of around 24 months. It is expected that approximately two patients will be recruited each month. Phase I, the initial dose escalation phase, will take place to identify the recommended Phase II dose. In this phase, MK-0752 will be administered orally on Days 1, 8, 15 and 22 of a 28-day cycle. There will be an initial two weeks at the start of each patient??s treatment where they receive MK-0752 alone (Day -14 and Day -7, Cycle 1 only). The starting dose will be 1200 mg. Gemcitabine will be given intravenously on Days 1, 8 and 15 of a 28 day cycle as a 800 mg/m2 or 1000 mg/m2 dose. Two patients will be treated at each dose level. Once two patients have completed the first cycle of treatment (Day 28), data will be incorporated into a computer program used by the Lancaster University to determine what the next level of drug administration will be. The decision to dose escalate and number of patients to be treated at any given dose level (beyond two patients) will be made by the DDO and the Investigators after review of all available toxicity data and output from the Lancaster University program. Approximately 27 patients will be treated at the MTD as determined from the Bayesian adaptive model. Patient recruitment will continue until approximately 27 patients are evaluable for response at 12 weeks.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/3

• Date of REC Opinion

  23 Mar 2010

• REC opinion

  Further Information Favourable Opinion