B2151002: Phase 1b of PF-05212384 in combination.

• Research type

  Research Study

• Full title

  A Phase 1B open-label three-arm multi-center study to assess the safety and tolerability of PF-05212384 (PI3K/mTOR inhibitor) in combination with other anti-tumor agents

• IRAS ID

  133229

• Contact name

  Rebecca Kristeleit

• Contact email

  r.kristeleit@ucl.ac.uk

• Sponsor organisation

  Pfizer Inc.,235 East 42nd Street, New York, NY 10017

• Eudract number

  2013-001390-24

• ISRCTN Number

  n/a

• Research summary

  This is a Phase 1b, three-arm, open-label, multi-center, multiple dose, dose escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-05212384 in combination with other anti-tumor agents in sequential cohorts of adult patients with select advanced solid tumors. Successive cohorts of patients will receive selected doses of PF-05212384 in combination with selected doses of chemotherapeutic agents or dacomitinib in 3 independent arms on an outpatient basis.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  13/SC/0503

• Date of REC Opinion

  28 Jan 2014

• REC opinion

  Further Information Favourable Opinion