Phase 2 study of PQR309 in Patients with Relapsed/Refractory Lymphoma

• Research type

  Research Study

• Full title

  Open-label, non-randomized, Phase 2 study with safety run-in evaluating efficacy and safety of PQR309 in Patients with Relapsed or Refractory Lymphomas

• IRAS ID

  170938

• Contact name

  Graham Collins

• Contact email

  Graham.Collins@ouh.nhs.uk

• Eudract number

  2014-005384-33

• Duration of Study in the UK

  1 years, 4 months, 21 days

• Research summary

  This is an open label non randomized Phase 2 study with safety run-in evaluating efficacy and safety of PQR309 in patients with refractory or relapsed lymphomas. The study will be split into 2 parts. The first part will be a safety run-in and will follow a modified 3+3 design and will evaluate the safety of PQR309 at 60mg and 80mg doses. The next part will be the Phase 2 expansion and will be conducted at the highest dose level (either 60mg or 80mg daily) that is considered to be safe by the investigators and the sponsor. Patients will receive the same dose throughout the study until disease progression or unacceptable toxicity occurs.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  15/SC/0009

• Date of REC Opinion

  18 Feb 2015

• REC opinion

  Further Information Favourable Opinion