E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Pregnancy growing outside of womb. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014166 |
E.1.2 | Term | Ectopic pregnancy |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
GEM 3 - Mechanistic study |
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E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The need for surgical intervention for treatment of EP (salpingectomy/salpingostomy by laparoscopy/laparotomy)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Three months post treatment
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 50 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last questionnaire received. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 30 |