A phase I study of AR-12 in Patients with Cancer

• Research type

  Research Study

• Full title

  A Phase 1 Study of AR-12 (2-Amino-N-[4-[5-(2-phenanthrenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]phenyl]-acetamide) in Adult Patients With Advanced or Recurrent Solid Tumors or Lymphoma for Which No Standard Therapy Is Available

• IRAS ID

  18324

• Sponsor organisation

  Arno Therapeutics

• Eudract number

  2009-014285-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a research study of a new investigational drug called AR-12 in patients with Advanced or Recurrent Solid Tumours or Lymphoma.AR-12 is a novel anti-cancer agent that inhibits PDK1 and PKB/AKT signalling and this is the first time it will be tested in human beings.Patients who are eligible for this study will have advanced or recurrent cancer for which no effective treatment exists. These patients have limited options for treatment and generally poor outcomes, therefore it is important to find new chemotherapeutic agents to treat them.Eligible patients who decide to take part in the study will be treated with AR-12 capsules once a day for 28 days (This is called a cycle of treatment.) Cycles of treatment may be repeated until the disease gets worse or the patient and/or doctor decide that treatment should be stopped.The study will take place in 3 centres, 2 in the USA and one in the UK, which is at the Royal Marsden Hospital in Surrey. Up to 50 patients will participate.Patients will visit the hospital regularly during the study and will undergo a number of investigations and tests which are designed to gather a better understanding of AR-12 and its effect in the human body.These investigations will include discussing their condition with the doctors and study staff at each visit, physical examinations, blood and urine tests, chest x ray, blood pressure, pulse and temperature recording, ECGs (heart trace), and possibly a CT or MRI scan.Patients will be carefully monitored throughout the study for any side-effects or changes in their condition and will have a contact number to call in case of any problems or questions that may arise.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/74

• Date of REC Opinion

  23 Sep 2009

• REC opinion

  Favourable Opinion