Oral artesunate in metastasized cervix carcinoma
| ISRCTN | ISRCTN81098537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81098537 |
| Secondary identifying numbers | KEMRI SSC 1787 |
- Submission date
- 23/06/2010
- Registration date
- 21/07/2010
- Last edited
- 21/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alice Musibi
Scientific
Scientific
Centre for Clinical Research (KEMRI)
5th Avenue Suites-Ngong Road
6th Floor
P.O. Box 19829
Nairobi
00202
Kenya
Study information
| Study design | Open-label single centre non-randomised dose-escalating phase I trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An open-label single centre dose-escalating phase I trial of oral artesunate in patients with metastasized cervix carcinoma |
| Study objectives | To determine the maximum tolerated dose (MTD) and the efficacy of orally administered artesunate in patients with metastasized cervical carcinoma. |
| Ethics approval(s) | Kenya Medical Research Institute (KEMRI) National Ethics Review Committee approved on the 11th May 2010 (ref. KEMRI SSC 1787) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Artesunate |
| Primary outcome measure | 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 study start date | 01/07/2010 |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Kenya
Study participating centre
Centre for Clinical Research (KEMRI)
Nairobi
00202
Kenya
00202
Kenya
Sponsor information
Dafra Pharma Research and Development (Belgium)
Industry
Industry
Slachthuisstraat 30 bus 7
Turnhout
2300
Belgium
| Website | http://www.dafra.be/start.html |
|---|
Funders
Funder type
Industry
Collaborative Programme Between:
No information available
Dafra Pharma Research and Development (Belgium)
No information available
Kenya Medical Research Institute (KEMRI) (Kenya)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
