GEM for Ectopic Pregnancies: Phase I

• Research type

  Research Study

• Full title

  Combination gefitinib and methotrexate to treat ectopic pregnancies: Phase I clinical trial

• IRAS ID

  71757

• Contact name

  Andrew Horne

• Sponsor organisation

  Monash University

• Eudract number

  2010-024507-27

• ISRCTN Number

  ACTRN12610000684022

• Research summary

  In this application, we propose moving an exciting concept conceived and developed in the laboratory, into the clinic. We believe that it may be possible to medically cure stable ectopic pregnancies (pregnancies implanted outside the womb)of any size with a single injection of methotrexate and a course of up to seven tablets of gefitinib, avoiding surgery. It could become the way 80-90% of ectopics are treated, medicalising a surgical disorder and revolutionising its management.We propose a Phase I dose-escalation toxicity trial of 12 women with small, stable ectopic pregnancies that would meet current criteria for medical managment. We plan to treat them with the standard single dose of methotrexate and up to seven days of oral gefitinib.We expect the regimen to be well tolerated, safe, and to efficaciously cure all ectopic pregnancies. If successful, we plan to proceed to Phase II studies of efficacy in stable ectopic pregnancies of any size.

• REC name

  Scotland A REC

• REC reference

  11/MRE00/2

• Date of REC Opinion

  28 Feb 2011

• REC opinion

  Further Information Favourable Opinion