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

Locations

5
Pusat Perubatan Universiti Malaya59100, Kuala LumpurKuala Lumpur, Malaysia
Institut Kanser Negara62250, PutrajayaKuala Lumpur, Malaysia
Hospital Umum Sarawak93586, KuchingSarawak, Malaysia
Hospital Ampang68000, AmpangSelangor, Malaysia

Sponsors and collaborators

Metanoic Health Ltd.

Lead sponsor

Clinical Research Malaysia

Collaborator