MK4827 with chemotherapy in patients with advanced solid tumors

• Research type

  Research Study

• Full title

  A Phase Ib Dose Escalation Study of MK-4827 in Combination with Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients with Advanced Solid Tumours

• IRAS ID

  40579

• Contact name

  Stan Kaye

• Eudract number

  2010-018358-10

• ISRCTN Number

  ISRCTN

• Research summary

  This is a multi-center, open-label, non-randomized, dose escalation and confirmation study of MK4827 in combination with carboplatin, carboplatin/paclitaxel and carboplatin/liposomal doxorubicin in patients with advanced solid tumours. The study will have two parts. The purpose of the first part of the study is to determine the maximum tolerated dose (MTD) and safety profile of MK4827 administered orally for the first 4 days of each 21 day cycle in combination with carboplatin. Carboplatin will be given intravenously on day 3 of each cycle. If an effective dose of MK-4827 administered in combination with carboplatin is generally well tolerated part 2 of the study will proceed. The purpose of the second part of the study is to determine the maximum tolerated dose (MTD) and safety profile of MK-4827 given in combination with carboplatin/paclitaxel or carboplatin/liposomal doxorubicin. Worldwide up to approximately 105 eligible patients will be enrolled. The final number will depend on safety data and observed dose limiting toxicities (DLTs).

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/29

• Date of REC Opinion

  3 Jun 2010

• REC opinion

  Further Information Favourable Opinion