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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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer, Locally Advanced Breast Cancer

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Trial Information

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


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


Inclusion Criteria:



- Patients with histologically or cytologically confirmed breast cancer

- Distant metastases or locally advanced breast cancer

- Age ≥ 18 years

- ECOG performance ≤ 2

- Life expectancy of at least 6 months

- Written informed consent

- individual standard therapy according to guidelines

- Oral intake of trial medication possible

- Compliance with study procedures

- Women of childbearing potential: negative pregnancy test before start of medication

- Use of a highly effective method of birth control during intake of add-on therapy for
women of childbearing potential being sexually active

Exclusion Criteria:

- Allergy to artesunate or to other artemisinin derivatives

- Concurrent conditions interfering with patient safety

- Communication problems

- Concurrent participation in another clinical trial or 4 weeks prior to recruitment

- Participation in a clinical trial with an unapproved drug 6 months prior to
recruitment

- Sinus bradycardia, bradyarrhythmia

- AV-Block II° and III°

- QTc > 500 msec

- Previously known long QT-syndrome

- Concurrent intake of a medication with clinically relevant neurotoxicity or during 30
days prior to recruitment

- Relevant neurological symptoms which might complicate the evaluation of the
compatibility of the IMPD (f. e. cerebral metastases) or might be subject to
worsening during intake of the IMPD

- Radiotherapy 2 weeks prior of the intake of the IMPD

- Concurrent intake of supplements or any other medication with unapproved efficacy
f.e. vitamins, minerals or others (OTC)

- Pregnancy and lactation

- Ineffective mode of contraception in women of childbearing potential

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy

Outcome Time Frame:

8-12 weeks

Safety Issue:

Yes

Principal Investigator

Cornelia U v. Hagens, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Gynecological Endocrinology and Reproductive Medicine

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

M33/2

NCT ID:

NCT00764036

Start Date:

October 2008

Completion Date:

September 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Locally Advanced Breast Cancer
  • phase I
  • safety
  • Breast Neoplasms

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