GEM study for ectopic pregnancy

Combination gefitinib and methotrexate to treat ectopic pregnancies II - GEM for Ectopic Pregnancies II

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001747-69-GB

Enrollment

Registered

2011-09-28

Start date

2011-10-28

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ectopic pregnancy or pregnancy of unknown location. MedDRA version: 14.0 Level: PT Classification code 10014166 Term: Ectopic pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: Iressa Product Name: Gefitinib ("Iressa") Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women aged between 18 and 45 inclusive 2. Women with serum hCG greater than 5 3. Women with either a mass which on ultrasound has the appearance of an ectopic pregnancy or a pregnancy of unknown location 4. No clinical evidence of intra-uterine bleeding 5. No pallor 6. No guarding/rigidity on abdominal examination 7. Stable blood pressure and heart rate 8. Normal haemaglobin on full blood examination at day 1. 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. History of significant pulmonary disease (eg lung carcinoma including mesothelioma, chronic obstructive airways disease, emphysema, pneumonitis, silicosis, pulmonary fibrosis, severe/brittle asthma, ILD) 2. Abnormal liver indices 3. Abnormal renal indices 4. Abnormal haematological indices 5. Significant pre-existing dermatological condition (eg psoriasis, excema) 5. Significant pre-existing gastrointestinal illness (eg inflammatory bowel disease, bowel carcinoma) 6. Japanese ethnicity.

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to show that combination therapy of gefitinib and methotrexate is more effective in the treatment of unruptured ectopic pregnancies and pregnancies of unknown location than methotrexate alone and therefore decrease the number of women requiring surgery for this condition and increase the success rate of medical treatment as well is increasing the number of women eligible for this medical management.;Secondary Objective: To collect data on the efficacy of this drug combination.;Primary end point(s): Tracking successful resolution of the ectopic pregnancy: this will be done using the existing protocols available to track resolution of ectopic pregnancies after medical management of single agent MTX. Serum hCG will be measured at day 1, 4 and 7. The medical treatment will be deemed to be working if serum hCG drops by at least 15% from day 4 to 7, and continues to drop with weekly measurements. Cure will be evidenced by the fact that hCG levels drop below 5 iu/l (lower limit of the assay). In addition, we will be in contact with the patient regularly and on a daily basis for the first week. We will ask the patients to attend for examination if they describe symptoms of possible rupture of the ectopic pregnancy (eg increasingly severe abdominal pain, dizziness).;Timepoint(s) of evaluation of this end point: We plan to see patients on day of treatment - Day 1 - then Day 4 and 7 when they attend for scheduled appointments at the Pregnancy Support Centre. We will telephone them on days 2,3,5,6 to ask about any adverse events. We will then follow them to resolution of their ectopic when their serum hCG is below 5 iu/l. This time cannot be defined. We will then contact them at 3, 6 , 12 and 24 months to gather information about their mentrual and pregnancy history.	—

Measure

Time frame

Main Objective: We aim to show that combination therapy of gefitinib and methotrexate is more effective in the treatment of unruptured ectopic pregnancies and pregnancies of unknown location than methotrexate alone and therefore decrease the number of women requiring surgery for this condition and increase the success rate of medical treatment as well is increasing the number of women eligible for this medical management.;Secondary Objective: To collect data on the efficacy of this drug combination.;Primary end point(s): Tracking successful resolution of the ectopic pregnancy: this will be done using the existing protocols available to track resolution of ectopic pregnancies after medical management of single agent MTX. Serum hCG will be measured at day 1, 4 and 7. The medical treatment will be deemed to be working if serum hCG drops by at least 15% from day 4 to 7, and continues to drop with weekly measurements. Cure will be evidenced by the fact that hCG levels drop below 5 iu/l (lower limit of the assay). In addition, we will be in contact with the patient regularly and on a daily basis for the first week. We will ask the patients to attend for examination if they describe symptoms of possible rupture of the ectopic pregnancy (eg increasingly severe abdominal pain, dizziness).;Timepoint(s) of evaluation of this end point: We plan to see patients on day of treatment - Day 1 - then Day 4 and 7 when they attend for scheduled appointments at the Pregnancy Support Centre. We will telephone them on days 2,3,5,6 to ask about any adverse events. We will then follow them to resolution of their ectopic when their serum hCG is below 5 iu/l. This time cannot be defined. We will then contact them at 3, 6 , 12 and 24 months to gather information about their mentrual and pregnancy history.

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Secondary

Measure	Time frame
Secondary end point(s): Incidence of side effects: we will document side effects by way of history, examination (if indicated) and investigation (day 4 and 7 renal function tests/liver function tests/full blood count. We will especially note the incidence of side effects specific to gefitinib (rash and lung symptoms indicating possible ILD) and MTX (nausea and vomiting, abdominal pain, neutropenia, liver toxicity). Tolerablility: we will note whether the regimen is well tolerated by way of history and examination (if indicated).	—

Measure

Time frame

Secondary end point(s): Incidence of side effects: we will document side effects by way of history, examination (if indicated) and investigation (day 4 and 7 renal function tests/liver function tests/full blood count. We will especially note the incidence of side effects specific to gefitinib (rash and lung symptoms indicating possible ILD) and MTX (nausea and vomiting, abdominal pain, neutropenia, liver toxicity). Tolerablility: we will note whether the regimen is well tolerated by way of history and examination (if indicated).

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Countries

Australia, United Kingdom

Contacts

Public ContactAnn Doust

University of Edinburgh

ann.doust@ed.ac.uk01312429492

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026