Trial of ARQ 197 for Subjects with Germ Cell Tumours

• Research type

  Research Study

• Full title

  Multicenter Phase 2 Trial of ARQ 197 for Subjects with Relapsed or Refractory Germ Cell Tumors

• IRAS ID

  36064

• Contact name

  Alan Horwich

• Sponsor organisation

  Daiichi Sankyo Pharma Development

• Eudract number

  2009-015400-26

• ISRCTN Number

  n/a

• Research summary

  This is a multicenter, Phase 2 clinical study of an investigational drug, ARQ 197, for patients with cancerous tumours, including testicular and non-central nervous system tumours. Approximately 40 male patients, 16 years and older, will be enrolled in this study at up to 15 sites in the United States and Europe. During an initial Screening Period written informed consent will be taken, the patient's medical history will be recorded & specific screening tests performed. All eligible patients will then enter the Treatment Period during which time they will be treated with the study drug at a dose of 360mg, twice a day, by mouth. The overall Treatment Period will be divided into continuous 28-day cycles without treatment interruption. During this period participants will undergo the following tests & procedures: physical examinations; vital signs & height & weight recorded; blood samples taken for clinical laboratory safety tests; urine samples taken for testing; electrocardiograms; chest X-ray; possible tumour biopsy; tumour measurement; and additional blood samples taken for serum biomarkers, plasma pharmacodynamics, pharmacogenomics and pharmacokinetic testing. The duration of a patient's participation in the study will depend on how their cancer responds to the study drug. There is no limit to the number of treatment cycles that can be administered. Patients will be able to continue on the study treatment until their disease progresses, they experience unacceptable side effects, or they withdraw their consent to participate. Each patient will be contacted during a Follow-up Period for a maximum of 12 months.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  10/H0504/17

• Date of REC Opinion

  12 Apr 2010

• REC opinion

  Further Information Favourable Opinion