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ISRCTN
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ISRCTN81098537
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ClinicalTrials.gov identifier
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Public title
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Oral artesunate in metastasized cervix carcinoma
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Scientific title
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An open-label single centre dose-escalating phase I trial of oral artesunate in patients with metastasized cervix carcinoma
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Acronym
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N/A
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Serial number at source
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KEMRI SSC 1787
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Study hypothesis
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To determine the maximum tolerated dose (MTD) and the efficacy of orally administered artesunate in patients with metastasized cervical carcinoma.
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Lay summary
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Ethics approval
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Kenya Medical Research Institute (KEMRI) National Ethics Review Committee approved on the 11th May 2010 (ref. KEMRI SSC 1787)
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Study design
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Open-label single centre non-randomised dose-escalating phase I trial
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Metastasized cervix carcinoma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2010
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Anticipated end date
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01/03/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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15
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Objective tumour response and correlation to expression of markers in tumor biopsy samples, assessed after the treatment period of 28 days.
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Sources of funding
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Collaborative Programme Between:
1. Dafra Pharma Research and Development (Belgium)
2. Kenya Medical Research Institute (KEMRI) (Kenya)
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Trial website
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Publications
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Contact name
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Dr
Alice
Musibi
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Address
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Centre for Clinical Research (KEMRI)
5th Avenue Suites-Ngong Road
6th Floor
P.O. Box 19829
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City/town
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Nairobi
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Zip/Postcode
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00202
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Country
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Kenya
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Sponsor
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Dafra Pharma Research and Development (Belgium)
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Address
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Slachthuisstraat 30 bus 7
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City/town
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Turnhout
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Zip/Postcode
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2300
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Country
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Belgium
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Sponsor website:
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http://www.dafra.be/start.html
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Date applied
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23/06/2010
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Last edited
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21/07/2010
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Date ISRCTN assigned
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21/07/2010
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