A Phase 2 Study of ARQ 197 in Patients with MiT Tumours

• Research type

  Research Study

• Full title

  A Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Associated Tumors

• IRAS ID

  23664

• Eudract number

  2009-011669-10

• ISRCTN Number

  Not available

• Research summary

  This is a multi-center, single arm, two-stage phase 2 study in patients with microphthalmia transcription factor associated (MiT) tumours. These tumours are a group of tumours that include clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS) and translocation-associated renal cell carcinoma (RCC)The MiT tumours have no accepted or effective therapies at present and have been shown to be dependent on C-Met over expression. ARQ197 is a well tolerated and an effective c-Met inhibitor.The study will enrol adolescent (age 13 or older) and adult patients with a histologically or cytologically confirmed MiT tumor. Patients must meet all eligibility criteria to be enrolled. Eligible patients enrolled under this protocol amendment (amendment 1) will receive 360 mg of oral ARQ 197 twice daily. The treatment will be continued until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. Thirty-nine evaluable patients will be enrolled in this study from up to 12 study sites. There will be only one site in the UK, which it is anticipated will recruit 4 patients with a maximum of 10 patients all over 16 years old.The trial closed at the end of 2010.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/45

• Date of REC Opinion

  18 Sep 2009

• REC opinion

  Further Information Favourable Opinion