Combination Gefitinib and Methotrexate to Medically Treat Ectopic Pregnancies: A Phase I Clinical Toxicity Trial.
Phase 1
Completed
- Conditions
- Clinically stable ectopic pregnanciesReproductive Health and Childbirth - Other reproductive health and childbirth disorders
- Registration Number
- ACTRN12610000684022
- Lead Sponsor
- Dr Stephen Tong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 12
Inclusion Criteria
Women diagnosed with stable ectopic pregnancy, with an hCG of less than 3000 IU/L and an ultrasound showing a gestational sac of under 3 cms.
Exclusion Criteria
Haemodynamic instability, women of Japanese ethnicity, chronic lung problems/lung cancer history, severe dermatological and gastrointestinal disease history, liver or renal dysfunction, allergy to gefitinib/methotrexate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure of ectopic pregnancy, evidenced by serum quantitative human chorionic gonadotrophin (hCG) levels of zero.[Serum hCG is a biomarker of ectopic pregnancy viability. Levels of serum hCG will be measured at days 4, day 7 and then measured weekly through to zero.];Documentation of tolerability (ie side effects) and toxiciy.<br><br>This will be assessed by:<br>History taking by a medical practitioner (at least daily for the first three days, then at weekly clinic visits) <br>Examination of participants undertaken by a medical practitioner (at least daily for the first three days then weekly clinic visits).<br><br>Investigations:<br>Day 4 and 7 blood tests: liver function test, renal function test (U/E/C), full blood test (FBE).[This will continue until there is final evidence of cure (hCG reaches zero).]
- Secondary Outcome Measures
Name Time Method one[None]