Trials / Completed
CompletedNCT00764036
Study of Artesunate in Metastatic Breast Cancer
Prospective Open Uncontrolled Phase I Study of Compatibility, Safety&Pharmacokinetics of Artesunate, a Semisynthetic Derivative of Artemisinin From the Chinese Herb Artemisia Annua in Patients With Metastatic/Locally Advanced Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Heidelberg University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluation the tolerability of an add-on therapy with artesunate with a duration of 4 weeks in patients with advanced breast cancer.
Detailed description
Additional objectives are: * parallel sampling of blood and saliva for the determination of drug concentrations and pharmacokinetic parameters in a substudy on the day of first application and during steady state * attempt to establish a therapeutical drug monitoring * collection of further safety data during prolonged add-on treatments (compassionate use)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | artesunate | add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2008-10-01
- Last updated
- 2017-08-01
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00764036. Inclusion in this directory is not an endorsement.