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Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer

ConditionCIN 2/3
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMetanoic Health Ltd.

About this trial

NeoART-CIN is a Phase II clinical study evaluating the safety and effectiveness of oral artesunate in patients with pre-cancerous cervical intra-epithelial neoplasia (CIN2/3), to investigate if a course of treatment with oral artesunate can reverse pre-cancerous changes in the cervix and prevent the development and progression of invasive cancer. Findings from this study will increase our understanding of the effects of artesunate on CIN2/3 and if confirmatory inform future clinical studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 or over

Histologically proven HPV positive cervical CIN2/3

WHO performance status 0-2

White Cell Count (WCC) >3.0 x 109 /l;

Disqualifiers

• Contraindication to the use of artesunate due to hypersensitivity

Pregnancy or lactation

Weight < 52 kg

History of previous CIN

Trial design

Design model

Single group

Treatments tested in this trial

  • Artesunate

    Drug

    Patients with HPV positive CIN2/3 will receive 3 cycles of oral artesunate 200mg OD prior to standard of care therapeutic LLETZ. Each 21 day treatment cycle will comprise oral artesunate 200mg OD for 14 days followed by a 7 day treatment break.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: ArtesunateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Histological regression of CIN2/3 on colposcopy and biopsy at Day 90

Histological regression will be defined as histologic regression to CIN1 or less.

Time frame
From enrolment to end of trial at Day 90

Secondary outcomes

1

HPV DNA viral clearance at Day 90.

Viral clearance will be defined as absence of HPV genotoype (s) detected at baseline.

Time frame
Measured at the end of the trial at Day 90
2

Change in Vaginome Composition

Vaginal microbiota composition will be assessed using gene sequencing of vaginal swab samples collected at Day 1, Day 64, and Day 90. Changes in microbial diversity and relative abundance of dominant bacterial genera (e.g., Lactobacillus, Gardnerella) will be compared across time points. Microbial community structure will be analysed to evaluate shifts associated with the study intervention. Unit of Measure: Relative abundance (%), alpha diversity index, beta diversity distance metrics

Time frame
At Day 1 , Day 64 of enrolment and at the end of the trial at Day 90
3

Change in Gut Microbiome Composition Assessed

Gut microbiota composition will be assessed using gene sequencing of stool samples collected at Day 1, Day 64, and Day 90. Outcomes will include changes in relative abundance of dominant phyla (e.g., Firmicutes, Bacteroidetes), as well as measures of microbial diversity (alpha and beta diversity). Differences in community structure over time will be evaluated in relation to treatment exposure. Unit of Measure: Relative abundance (%), alpha diversity index, beta diversity distance metrics

Time frame
At Day 1 , Day 64 of enrolment and at the end of the trial at Day 90
4

Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
Assessment at Day 90 following study intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Metanoic Health Ltd.

Lead sponsor

Clinical Research Malaysia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: