Condition category
Cancer
Date applied
23/06/2010
Date assigned
21/07/2010
Last edited
21/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alice Musibi

ORCID ID

Contact details

Centre for Clinical Research (KEMRI)
5th Avenue Suites-Ngong Road
6th Floor
P.O. Box 19829
Nairobi
00202
Kenya

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

http://www.dafra.be/start.html

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

Publication citations

Additional files

Editorial Notes