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

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

Treatments tested in this trial

  • Artesunate

Treatment groups

28 Participants
are divided into 1 treatment group

Sponsors and collaborators

Metanoic Health Ltd.

Lead sponsor

Clinical Research Malaysia

Collaborator