A Phase I study of MK-8242 in patients with Advanced Solid Tumours

• Research type

  Research Study

• Full title

  A Phase 1 Study to Evaluate the Safety and Tolerability and Pharmacokinetics/Pharmacodynamics of MK-8242 in patients with Advanced Solid Tumours(Protocol P07650)

• IRAS ID

  84917

• Contact name

  Udai Banerji

• Sponsor organisation

  Merck Sharpe & Dohme Corp

• Eudract number

  2011-001346-15

• ISRCTN Number

  isrctn

• Research summary

  MK-8242 is being developed as a novel oral anti-cancer agent. The growth of cancer cells are regulated by a balance of the action of oncogenes (genes which make cancer cells grow) and tumour suppressor genes (genes that prevent cancer cells from growing). P53 is one such tumour suppressor gene that is crucial to stopping the growth of cancer cells. HDM2 is a substance within a cell that normally reduces the efficiency of P53 by binding to it and degrading it, thus allowing cancer cells to grow. MK-8242 inhibits HDM2, allowing P53 to function and arrest cancer cell growth. It is however important that for MK-8242 to work, that P53 itself is normal, as increasing the amount of abnormal P53 would probably not stop cancer cells from growing. Thus in the latter part of the trial in order to enrich the chances of the patient to benefit, only patients whose tumours have normal P53 will be included.This is a global non randomized study being conducted at approximately 6 global sites including a UK site with a total of 136 patients. The study has two parts, a dose escalation part 1, followed by a dose conformation part 2. The primary aim of part 1 is to define a safe dose of the drug and a maximum of 84 patients will be included in this phase. Secondary aims include studying the amount of drug in the body (pharmacokinetics) and effects of the drug on the body (pharmacodynamics). Approximately 52 further evaluable patients would be entered into part 2 of the study to further clarify tolerability, pharmacokinetics and pharmacodynamics in addition to exploring the efficacy MK-8242 in specific tumour types.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/1399

• Date of REC Opinion

  8 Nov 2011

• REC opinion

  Further Information Favourable Opinion