Ectopic pregnancy MedDRA version: 20.0 Level: PT Classification code 10014166 Term: Ectopic pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: Iressa
Product Name: Iressa
Product Code: EU/1/09/526/001
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Gefitinib
CAS Number: 184475-35-2
Concentration unit: mg milligram(s)
Con
Sponsors
ACCORD office
NHS Lothian R&D Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MAIN STUDY • Clinical decision made for treatment of EP with MTX • Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent • Women 18-50 years at time of randomisation • Diagnosis of; 1. definite tubal EP (extrauterine gestational sac with yolk sac and/or embryo, without cardiac activity on USS) or 2. clinical decision of probable EP (extrauterine sac-like structure or inhomogeneous adnexal mass on USS with a background of sub optimally rising serum hCG concentrations) • Pre-treatment serum hCG level of 1000–5000 iu/l (within 1 calendar day of treatment ) • Clinically stable • Haemoglobin between 100 and 165 g/L within 3 calendar days of treatment • Able to comply with treatment and willing to participate in follow up • Not participating in any other clinical trial of a medicinal product or previous participation in GEM 3 trial. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 358 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: MAIN STUDY: • Women with a pregnancy of unknown location (PUL) • Breastfeeding • Hypersensitivity to gefitinib • Women with EP mass on ultrasound greater than 3.5cm • Women with evidence of intrauterine pregnancy • Evidence of significant intra-abdominal bleed on ultrasound defined by echogenic free fluid above the uterine fundus or surrounding ovary within1 calender day of treatment • Significant abdominal pain, guarding/rigidity • Clinically significant abnormal liver/renal/haematological indices noted within 3 calendar days of treatment • Significant pre-existing dermatological disease • Significant pulmonary disease • Significant gastrointestinal medical illness • Japanese ethnicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a randomised controlled trial. To see if taking methotrexate (MTX) in combination with gefitinib is better at reducing the need for surgery against methotrexate alone in the treatment of ectopic pregnancy. ;Secondary Objective: To see if taking MTX in combination with gefitinib is better than methotrexate alone in reducing the need for a further dose of MTX. To see if it will reduce the numbers of days until the pregnancy is resolved (pre-pregnancy hormone level of <=15 iu/l which could reduce the number of visits to the hospital. To see if the treatment is safe to use and that women can tolerate the treatment. To see if women are happy taking the treatment. ;Primary end point(s): The need for surgical intervention for treatment of EP (salpingectomy/salpingostomy by laparoscopy/laparotomy) ;Timepoint(s) of evaluation of this end point: End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SECONDARY CLINICAL OUTCOMES: 1) Additional MTX 2) time to hCG resolution (days) from randomisation to hCG level of =15 iu/l 3) number of treatment-associated hospital visits until resolution or scheduled/emergency surgery 4) safety/tolerability 5) Acceptability of treatment 6) Return to menstruation ;Timepoint(s) of evaluation of this end point: Three months post treatment | — |
Countries
United Kingdom
Outcome results
None listed