B1001001- PF-04605412 in adults with advanced/metastatic solid tumours

• Research type

  Research Study

• Full title

  A Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study Of The Anti-a5ß1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors

• IRAS ID

  24239

• Contact name

  Johann S DeBono

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2009-009294-95

• ISRCTN Number

  N/A

• Research summary

  Tumours require new blood vessels to support their ability to grow and spread (metastasise). New treatments aimed at preventing these blood vessels from forming could slow down or even stop this process. PF-04605412 is an antibody that blocks the ability of blood vessels to multiply and divide. In addition, PF-04605412 can activate the immune system to kill tumour cells. These effects on cancer have been shown in laboratory studies. It is hoped that by stopping the growth of new blood vessels, PF-04605412 will stop the growth and spread of the tumour itself. Purpose: This study will test the safety and effectiveness of PF-04605412 when given as a single agent to patients with solid tumours. PF-046-05412 has never been given to humans before Treatment: All participants in the study will receive PF-04605412 but some patients will receive the drug at a higher dose than others. A number of tests and examinations will be given throughout the study to monitor participants closely. Treatments will be stopped if a participant's cancer gets worse or if they have unacceptable side effects. This study is being funded by Pfizer Ltd. The study is being carried out in the UK and the USA (3 hospitals in total) and a total of approximately 60 patients will be included.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/90

• Date of REC Opinion

  28 Oct 2009

• REC opinion

  Further Information Favourable Opinion