EndometriosisPhase 1/2ELTANCT03481842
Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
A Phase 1/2 study testing Linifanib, BIBW2992 and Axitinib in people with Endometriosis and Endometriosis Ovary, run by BioGene Pharmaceutical Ltd. at 1 site in Switzerland.
Trial summary
Background: Endometriosis is a chronic gynecological disease with the growth of endometrial tissue outside the endometrium. In all its properties, this tissue is similar to the mucous membrane of the uterus. Types of endometriosis: Endometriosis is divided into genital and extragenital. Read more about this study
- Who is it for?
- Ages 19 to 60 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis Ovary, Endometriosis Externa
- What is being tested?
- Linifanib, BIBW2992 and Axitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2021to 10 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- verification of endometriosis
- signed agreement of informed consent
- agreement with information on the nature, relevance and scope of the investigation, as well as the expected results and undesirable consequences of IMD
Who cannot join
- use of not permitted contraception or not willing to use contraception
- pregnancy or lactation
- planned pregnancy in the next 36 months with the consent to participate in that clinical trial
- use of any other intravaginal medicinal product or medical device
- known hypersensitivity to one or more of the active and / or inactive ingredients
- acute or chronic renal failure
Show all 11Show fewer
- acute or chronic heart failure
- the patient's reluctance to follow the trial protocol
- chronic alcoholism
- drug addiction
- use of antidepressants (during participation in trial)
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Endometriosis is a chronic gynecological disease with the growth of endometrial tissue outside the endometrium. In all its properties, this tissue is similar to the mucous membrane of the uterus.
Read more
Types of endometriosis:
Endometriosis is divided into genital and extragenital. Genital endometriosis is internal and external. When the inner is affected by the uterus, with the external - the ovaries, tubes, vagina and external genital organs are affected. Extragenital endometriosis can affect various organs of the abdominal cavity.
Drug treatment does not show high effectiveness. Surgery / laparoscopic is currently considered the gold standard treatment for this problem, including infertility treatment.
The purpose of our studies is to achieve substantial results with respect to tolerability, safety and clinical efficacy of vaginal suppository ELTA for treatment of the endometriosis.
Methods:
Phase I clinical trial to be conducted at Cancer Center to hold under the aegis UniversitätsSpital Zürich from May 2018 to September 2018.
Ninety-four patients with the form of genital endometriosis will take part in the studies. The study was approved by the Ethics Committee at the Cancer Institute no C99884.01FH339
Read the detailed description
The composition of the endometrium includes epithelial cell layers lining the uterine cavity, and deeper stroma, including the secretory glands. Each layer is characterized by the presence of a large number of blood vessels, through which a sufficient amount of blood is delivered. A large number of these vessels and arteries go to the surface layers due to myometrium and form a capillary network in the stroma.
In the vaginal suppositories, the investigators applied minimally therapeutic doses of inhibitors of neoangiogenesis, as well as other components that caused the pathological growth of the endometrium.
Anti-angiogenic therapy - inhibition of proliferative processes in the vascular wall of capillaries and small vessels in the endometrium, is the determining factor of the therapeutic effect of endometriosis when treated with vaginal suppositories.
The composition of the suppository:
- Axitinib, Afatinib, Linifanib (ABT-869) in a minimally sufficient therapeutic doses
- Auxiliary substances that ensure a uniform release of active components from suppositories, taking into account the dependence of this process on the chemical nature of the basis, surfactant, dissolution medium. (the composition and amount of excipients are maximally optimal for bioavailability of drugs from suppositories, taking into account the pharmacokinetics, pharmacodynamics and synergy of active drugs) This therapy has a slight teratogenic effect, which should be taken into account when planning pregnancy.
- Being tested
- Linifanib, BIBW2992, Axitinib
- Keywords
- Endometriosis, VEGF(R)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinifanibBiological
Also called ABT869
in a minimally sufficient therapeutic dose
BIBW2992Drug
Also called Afatinib, Giotrif
in a minimally sufficient therapeutic dose
AxitinibDrug
Also called AG013736;, Inlyta
in a minimally sufficient therapeutic dose
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Suppositories | Experimental | Daily single administration of vaginal suppository in diagnosed endometriosis. Duration of admission-five days, two days-off. The total duration of treatment is 6 weeks. General course -30 vaginal suppositories ELTA
The composition of the suppository:
* Axitinib (inhibitor of VEGFR1, VEGFR2, VEGFR3, PDGFRβ and c-Kit) in a minimally sufficient therapeutic dose
* Afatinib (BIBW2992) EGFR / HER2 including EGFR (wt), EGFR (L858R), EGFR (L858R / T790M) and HER2 inhibitor - minimally sufficient therapeutic dose
* Linifanib (ABT-869) ATP-competitive VEGFR / PDGFR inhibitor for KDR, CSF-1R, Flt-1/3 and PDGFRβ - minimally sufficient therapeutic dose Receives: Biological: Linifanib; Drug: BIBW2992; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tolerability of the vaginal suppository ELTA defined as a cumulative sum of clinical signs for each patient
Local tolerability of the vaginal suppositories ELTA will be defined as a cumulative sum score of the solicited local /vaginal (consisting of subjectively experienced symptoms rated by the patient: burning, itching, bleeding, pain, dryness and objectively documented findings rated by the physician: redness, petechial bleeding, dryness, swelling) for each patient after every weeks of application (scored from 0 [none/normal] to 5 [severe]) Weekly visit of patients every seventh day from the beginning of treatment.
SCALE EVALUATION EVENTS
- burning - 2 points,
- dryness - 1 point,
- painful symptom- 3 points,
- itching - 1 point,
- bleeding - 5 points,
If there is bleeding or the development of edema - the study for the patient will be stopped.
Measured: 6 weeks
Secondary outcomes (1)
Subjective symptoms (local tolerability)
Each of the subjective symptoms (scored from 0 [none/normal] to 5 [severe]) from the first visit (after the first application)/ A detailed description of the symptoms in each visit (with endoscopic photofixation of the endometriosis surface)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start10 Oct 2021 (estimated)
- Primary completion10 Oct 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Why it stopped: Change in study design and sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single application in the morning of a vaginal suppository ELTA: Five days per week (with a treatment-free interval of two days in a row.) e.g. Monday and Tuesday - treatment-free days.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGene Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481842
- Sponsor's protocol ID
- C99884.337/18
- Acronym
- ELTA
- Status last verified
- Oct 2021
- First submitted
- 8 Mar 2018
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
- ClinicalTrials.gov ID
- NCT03481842
- Acronym / sponsor ID
- ELTA / C99884.337/18
- Keywords
- Endometriosis, VEGF(R)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study design and sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioGene Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 10 Oct 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Endometriosis is a chronic gynecological disease with the growth of endometrial tissue outside the endometrium. In all its properties, this tissue is similar to the mucous membrane of the uterus.
Types of endometriosis:
Endometriosis is divided into genital and extragenital. Genital endometriosis is internal and external. When the inner is affected by the uterus, with the external - the ovaries, tubes, vagina and external genital organs are affected. Extragenital endometriosis can affect various organs of the abdominal cavity.
Drug treatment does not show high effectiveness. Surgery / laparoscopic is currently considered the gold standard treatment for this problem, including infertility treatment.
The purpose of our studies is to achieve substantial results with respect to tolerability, safety and clinical efficacy of vaginal suppository ELTA for treatment of the endometriosis.
Methods:
Phase I clinical trial to be conducted at Cancer Center to hold under the aegis UniversitätsSpital Zürich from May 2018 to September 2018.
Ninety-four patients with the form of genital endometriosis will take part in the studies. The study was approved by the Ethics Committee at the Cancer Institute no C99884.01FH339
Detailed description
The composition of the endometrium includes epithelial cell layers lining the uterine cavity, and deeper stroma, including the secretory glands. Each layer is characterized by the presence of a large number of blood vessels, through which a sufficient amount of blood is delivered. A large number of these vessels and arteries go to the surface layers due to myometrium and form a capillary network in the stroma.
In the vaginal suppositories, the investigators applied minimally therapeutic doses of inhibitors of neoangiogenesis, as well as other components that caused the pathological growth of the endometrium.
Anti-angiogenic therapy - inhibition of proliferative processes in the vascular wall of capillaries and small vessels in the endometrium, is the determining factor of the therapeutic effect of endometriosis when treated with vaginal suppositories.
The composition of the suppository:
- Axitinib, Afatinib, Linifanib (ABT-869) in a minimally sufficient therapeutic doses
- Auxiliary substances that ensure a uniform release of active components from suppositories, taking into account the dependence of this process on the chemical nature of the basis, surfactant, dissolution medium. (the composition and amount of excipients are maximally optimal for bioavailability of drugs from suppositories, taking into account the pharmacokinetics, pharmacodynamics and synergy of active drugs) This therapy has a slight teratogenic effect, which should be taken into account when planning pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single application in the morning of a vaginal suppository ELTA: Five days per week (with a treatment-free interval of two days in a row.) e.g. Monday and Tuesday - treatment-free days.
| Arm | Type | Receives |
|---|---|---|
| Vaginal Suppositories | Experimental | Biological: Linifanib, Drug: BIBW2992, Drug: AxitinibDaily single administration of vaginal suppository in diagnosed endometriosis. Duration of admission-five days, two days-off. The total duration of treatment is 6 weeks. General course -30 vaginal suppositories ELTA The composition of the suppository: * Axitinib (inhibitor of VEGFR1, VEGFR2, VEGFR3, PDGFRβ and c-Kit) in a minimally sufficient therapeutic dose * Afatinib (BIBW2992) EGFR / HER2 including EGFR (wt), EGFR (L858R), EGFR (L858R / T790M) and HER2 inhibitor - minimally sufficient therapeutic dose * Linifanib (ABT-869) ATP-competitive VEGFR / PDGFR inhibitor for KDR, CSF-1R, Flt-1/3 and PDGFRβ - minimally sufficient therapeutic dose |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- verification of endometriosis
- signed agreement of informed consent
- agreement with information on the nature, relevance and scope of the investigation, as well as the expected results and undesirable consequences of IMD
Key exclusion criteria (11 listed)
- use of not permitted contraception or not willing to use contraception
- pregnancy or lactation
- planned pregnancy in the next 36 months with the consent to participate in that clinical trial
- use of any other intravaginal medicinal product or medical device
- known hypersensitivity to one or more of the active and / or inactive ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinifanibAlso: ABT869in a minimally sufficient therapeutic dose | Biological | Vaginal Suppositories |
| BIBW2992Also: Afatinib, Giotrifin a minimally sufficient therapeutic dose | Drug | Vaginal Suppositories |
| AxitinibAlso: AG013736;, Inlytain a minimally sufficient therapeutic dose | Drug | Vaginal Suppositories |
Primary outcome
Local tolerability of the vaginal suppository ELTA defined as a cumulative sum of clinical signs for each patient
Time frame: 6 weeks
Local tolerability of the vaginal suppositories ELTA will be defined as a cumulative sum score of the solicited local /vaginal (consisting of subjectively experienced symptoms rated by the patient: burning, itching, bleeding, pain, dryness and objectively documented findings rated by the physician: redness, petechial bleeding, dryness, swelling) for each patient after every weeks of application (scored from 0 [none/normal] to 5 [severe]) Weekly visit of patients every seventh day from the beginning of treatment. SCALE EVALUATION EVENTS * burning - 2 points, * dryness - 1 point, * painful symptom- 3 points, * itching - 1 point, * bleeding - 5 points, If there is bleeding or the development of edema - the study for the patient will be stopped.
1 secondary outcome
Subjective symptoms (local tolerability)
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Linifanib, BIBW2992 and Axitinib in people with Endometriosis and Endometriosis Ovary, run by BioGene Pharmaceutical Ltd. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tolerability of the vaginal suppository ELTA defined as a cumulative sum of clinical signs for each patient (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.