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Trial registered on ANZCTR


Registration number
ACTRN12611001056987
Ethics application status
Approved
Date submitted
3/10/2011
Date registered
10/10/2011
Date last updated
25/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Combination Gefitinib and Methotrexate to Medically Treat Ectopic Pregnancies: A Phase II Study of Efficacy
Scientific title
Combination Gefitinib and Methotrexate to Medically Treat Ectopic Pregnancies: A Phase II Open-Label Single-Arm Study of Efficacy
Secondary ID [1] 273148 0
None
Universal Trial Number (UTN)
Trial acronym
GEM for EP: Phase II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinically stable ectopic pregnancies 278900 0
Condition category
Condition code
Reproductive Health and Childbirth 279076 279076 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50mg/m2 of intramuscular methotrexate on day 1 of treatment PLUS 250mg of oral gefitinib daily for seven days (day 1 to day 7 of treatment) PLUS/MINUS additional doses of 50mg/m2 IM methotrexate on day 7 if serum hCG has not fallen >15% between days 4 and 7 PLUS/MINUS additional dose of 50mg/m2 IM methotrexate on day 14 if serum hCG has not fallen >15% between days 11 and 14
Intervention code [1] 269486 0
Treatment: Drugs
Comparator / control treatment
This is a single-arm study as there is no obvious/ethical comparator or control treatment. Methotrexate alone is known not to be an effective treatment of larger ectopic pregnancies, and surgical management is known to be highly effective but removes the affected Fallopian tube and is a different form of treatment intervention. We consider it unethical to provide proven sub-standard treatment or placebo for this potentially life-threatening condition.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279723 0
Efficacy
(as assessed by serum hCG decline and time to cure in days - see Timepoint below for details)
Timepoint [1] 279723 0
Blood will be drawn from participants on days 1, 4, 7, 11 and weekly thereafter until hCG is normalised (<5IU/L), to determine treatment efficacy and ensure cure. Mean time to resolution of ectopic pregnancy with current medical treatment is approximately 35 days.
Secondary outcome [1] 294303 0
Toxicity
Timepoint [1] 294303 0
Daily clinical review as inpatients and outpatient clinical review on days 4, 7, 11 and weekly thereafter (i.e. ongoing) until cured. Biochemical (haematological, renal and hepatic function) measurement on days 4, 7, 11 and weekly until cured.

Eligibility
Key inclusion criteria
Women diagnosed with a haemodynamically stable ectopic pregnancy with any level of pre-treatment serum hCG.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Haemodynamic instability, women of Japanese ethnicity, chronic and/or severe history of lung disease including lung cancer history, history of severe gastrointestinal and dermatological conditions, hepatic or renal dysfunction on screening blood tests, allergy to gefitinib/methotrexate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through the Emergency Departments and outpatient clinics at Monash Medical Centre and Dandenong Hospital in Melbourne, Australia and The Royal Infirmary of Edinburgh, Scotland. Potential participants at all sites will have been diagnosed with a haemodynamically stable ectopic pregnancy by the on-call gynaecological team. A trial investigator will approach potential participants and provide information about the study and their treatment options. If they agree to participate, informed consent will be obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will receive the same treatment, so no randomisation or sequencing will take place.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/02/2012
Actual
23/02/2012
Date of last participant enrolment
Anticipated
31/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3879 0
United Kingdom
State/province [1] 3879 0
Edinburgh

Funding & Sponsors
Funding source category [1] 269966 0
University
Name [1] 269966 0
Monash Institute of Medical Research
Country [1] 269966 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Stephen Tong
Address
Level 4, Mercy Hospital for Women,
163 Studley Road,
Heidelberg, Victoria 3084.
Country
Australia
Secondary sponsor category [1] 268959 0
Individual
Name [1] 268959 0
Professor Euan Wallace
Address [1] 268959 0
Director of Maternity Services,
Department of Obstetrics and Gynaecology,
Level 5, Monash Medical Centre,
246 Clayton Road
Clayton Victoria 3168
Country [1] 268959 0
Australia
Other collaborator category [1] 252275 0
Individual
Name [1] 252275 0
Dr Monika Skubisz
Address [1] 252275 0
Department of Obstetrics & Gynaecology
Level 5, Monash Medical Centre,
246 Clayton Road,
Clayton Victoria 3168
Country [1] 252275 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271932 0
Southern Health Human Research Ethics Committee B
Ethics committee address [1] 271932 0
Ethics committee country [1] 271932 0
Australia
Date submitted for ethics approval [1] 271932 0
01/06/2011
Approval date [1] 271932 0
30/06/2011
Ethics approval number [1] 271932 0
11180B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33227 0
A/Prof Stephen Tong
Address 33227 0
Translational Obstetrics Group
Department of Obstetrics & Gynaecology
University of Melbourne
Mercy Hospital for Women
163 Studley Road
Heidelberg, Victoria 3084
Country 33227 0
Australia
Phone 33227 0
+61 3 8458 4377
Fax 33227 0
Email 33227 0
stong@unimelb.edu.au
Contact person for public queries
Name 16474 0
Dr Monika Skubisz
Address 16474 0
Department of Obstetrics and Gynaecology,
Level 5, Monash Medical Centre,
246 Clayton Road,
Clayton Victoria 3168
Country 16474 0
Australia
Phone 16474 0
+61395946666
Fax 16474 0
Email 16474 0
monika.skubisz@monash.edu
Contact person for scientific queries
Name 7402 0
Dr Monika Skubisz
Address 7402 0
Department of Obstetrics and Gynaecology,
Level 5, Monash Medical Centre,
246 Clayton Road,
Clayton Victoria 3168
Country 7402 0
Australia
Phone 7402 0
+61395946666
Fax 7402 0
Email 7402 0
monika.skubisz@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.