Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KEMRI SSC 1787
Study information
Scientific title
An open-label single centre dose-escalating phase I trial of oral artesunate in patients with metastasized cervix carcinoma
Acronym
Study hypothesis
To determine the maximum tolerated dose (MTD) and the efficacy of orally administered artesunate in patients with metastasized cervical carcinoma.
Ethics approval
Kenya Medical Research Institute (KEMRI) National Ethics Review Committee approved on the 11th May 2010 (ref. KEMRI SSC 1787)
Study design
Open-label single centre non-randomised dose-escalating phase I trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Metastasized cervix carcinoma
Intervention
Patients will be recruited in cohorts of three and the starting dose will be 100 mg. Based on dose limiting toxicity evaluations, decisions regarding dose escalation or de-escalation on the next cohort will be made. Every cohort corresponds to a dose escalation of 50 mg. Daily oral artesunate will be administrated for a period of 28 days.
Intervention type
Drug
Phase
Phase I
Drug names
Artesunate
Primary outcome measures
Determination of maximum tolerated dose (defined as one dose level below that at which dose limiting toxicity [DLT] is observed in two or more of the patients), assessed during the treatment period of 28 days.
Secondary outcome measures
Objective tumour response and correlation to expression of markers in tumor biopsy samples, assessed after the treatment period of 28 days.
Overall trial start date
01/07/2010
Overall trial end date
01/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Females aged 18 years or above
2. Diagnosed with cervix carcinoma stages IIIb, IVa and IVb
3. Overall good general condition (Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2)
4. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
15
Participant exclusion criteria
1. Contraindication to use of artesunate due to hypersensitivity
2. Pregnant at time of recruitment
3. Human immunodeficiency virus (HIV) positive
4. History of hearing or balance problems
5. Weight of less than 50 kg or greater than 100 kg
6. On concomitant medication known to interact with artesunate
7. The following laboratory values obtained within 14 days prior to recruitment:
7.1. Absolute neutrophil count (ANC) less than 1,000 cells/mm3
7.2. Haemoglobin lower than 9.0 g/dL
7.3. Platelet count less than 100,000/mm3
7.4. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), and alkaline phosphatase higher than 5 x upper limit of normal (ULN)
7.5. Total bilirubin higher than 1.5 x ULN
Recruitment start date
01/07/2010
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Kenya
Trial participating centre
Centre for Clinical Research (KEMRI)
Nairobi
00202
Kenya
Sponsor information
Organisation
Dafra Pharma Research and Development (Belgium)
Sponsor details
Slachthuisstraat 30 bus 7
Turnhout
2300
Belgium
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Collaborative Programme Between:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dafra Pharma Research and Development (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kenya Medical Research Institute (KEMRI) (Kenya)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary