Intellikine 1117-001

• Research type

  Research Study

• Full title

  A phase I, dose escalation study of INK1117 in subjects with solid malignancies followed by expansion in subjects with measurable disease.

• IRAS ID

  82276

• Contact name

  Johann DeBono

• Sponsor organisation

  Intellikine

• Eudract number

  2011-001971-37

• ISRCTN Number

  ISRCTN

• Research summary

  INK1117 is being developed by Intellikine Inc.(the study sponsor). It blocks a protein called PI3K. PI3K is part of the PI3K-AKT-MTOR signalling pathway which is the most commonly mutated (abnormal) in >90% of human cancers. When PI3K is mutated, it leads to the uncontrolled growth and spread of cancers.INK1117 has previously been shown to prevent or reduce the growth of tumours in laboratory experiments including animal studies; however, this is the first trial to be carried out in humans. The aims of this Phase I study are: to find the highest dose of the study drug INK1117 that can be given safely to humans (maximum tolerated dose, MTD), to study how the body handles INK1117 (pharmacokinetics, PK), and to see if INK1117 causes any changes to the tumour (pharmacodynamics, PD).Patients with advanced cancer who have exhausted all standard therapy will be offered this study. They will provided written informed consent. Patient's previous tumour biopsies will need to demonstrate a mutation in the PI3K protein to take part. They must meet other study specific criteria.INK1117 will be administered orally either daily continuously or intermittently in 21-day cycles in a dose escalation phase. Once the MTD of INK1117 has been determined, patients with PI3K mutated breast and other cancers will be treated at that MTD on an expansion phase. This is a standard design for a phase I trial. Patients will be monitored closely for side effects.Although benefit cannot be guaranteed, patients will continue dosing with INK1117 for as long as their cancer is not growing, are tolerating any side effects and wish to continue participating in the study.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/1094

• Date of REC Opinion

  7 Sep 2011

• REC opinion

  Further Information Favourable Opinion