Effect of Deforolimus in Endometrial Carcinoma Version 1.1

• Research type

  Research Study

• Full title

  A randomised phase II trial of deforolimus (AP23573; MK-8669) compared to progestin in female adult patients with advanced endometrial carcinoma following one line of chemotherapy Version 1.1

• IRAS ID

  6286

• Sponsor organisation

  ARIAD Pharmaceuticals, Inc.

• Eudract number

  2008-000634-53

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Deforolimus is being studied for its potentialto affect a protein called mTOR that controls other proteins that are neededfor cell growth, including the growth of cancer cells. This clinical trial willstudy the use of oral deforolimus in endometrial cancer patients who havereceived one prior chemotherapy regimen. The trial will determine if patientstreated with deforolimus experience a longer period without disease progressioncompared to patients receiving progestin and if treatment with deforolimusprolongs survival. This is a multi-centre, open-label, randomised, active-controlledphase 2 trial in patients with advanced, recurrent or metastatic cancer. Thisstudy will enrol approximately 150 patients in at least 50 centres worldwide.Eligible patients will be made aware of the study by individual investigatorsin oncology clinics of the participating institutions. Each patient will beevaluated for approximately 24 months and 2 weeks, including 2 weeks ofscreening tests and approximately six cycles of study drug administration. Allpatients will also be followed for 2 years after randomisation to capturesurvival information. Deforolimus is currently being evaluated in a variety ofcancers. Thus far, these trials have provided evidence that deforolimus has afavourable safety profile and possesses anti-tumour activity in a broad rangeof cancers including sarcomas and endometrial carcinomas. Prior clinicalresearch strongly supports the conclusion that single-agent deforolimus, amolecularly targeted agent, is well tolerated and has promising, sustainedanti-tumour activity. It is deemed safe to conduct a trial of oral deforolimusin comparison to hormone therapy. Patients will be carefully monitoredthroughout the study. The proposed research has been designed and will befunded by ARIAD Pharmaceuticals, Inc.

• REC name

  Scotland A REC

• REC reference

  08/MRE00/81

• Date of REC Opinion

  7 Nov 2008

• REC opinion

  Further Information Favourable Opinion