Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis

NCT03481842 | Withdrawn Phase 1 DMC

• 1 other identifier: C99884.337/18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Endometriosis; Endometriosis Ovary; Endometriosis Externa; Endometriosis, Rectum

Keywords

Endometriosis; VEGF(R)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

• Subjective symptoms (local tolerability)

  7 weeks

Other Outcomes (7)

• Objective findings

  7 weeks

• Global judgement of tolerability

  4 weeks

• Safety evaluation of therapy

  15 weeks

Study Arms (1)

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

Biological: Linifanib; Drug: BIBW2992; Drug: Axitinib

Interventions

Linifanib BIOLOGICAL

in a minimally sufficient therapeutic dose

Also known as: ABT869

Vaginal Suppositories

BIBW2992 DRUG

in a minimally sufficient therapeutic dose

Also known as: Afatinib, Giotrif

Vaginal Suppositories

Axitinib DRUG

in a minimally sufficient therapeutic dose

Also known as: AG013736;, Inlyta

Vaginal Suppositories

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• BioGene Pharmaceutical Ltd.: lead

Study Sites (1)

BioGene Pharmaceutical Ltd.

Basel, Вâlе, 4057, Switzerland

Location

MeSH Terms

Conditions

Endometriosis

Interventions

linifanib; Afatinib; Axitinib

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: October 10, 2021
• Primary Completion: October 10, 2021
• Study Completion: October 10, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

CH (1)