Phase I interaction study of docetaxel with supplementation of St. John's wort or Echinacea

Phase I interaction study of docetaxel with supplementation of St. John's wort or Echinacea - Interaction study of docetaxel and St. John's wort or Echinacea

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009427

Enrollment

Registered

2012-11-29

Start date

2009-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Docetaxel + Echinacea Docetaxel + St. John&#39

s wort

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients for whom treatment with docetaxel is considered to be of therapeutic benefit, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancer and prostate cancer - Histological or cytological proof of malignancy - Age: 18 years or older - Performance: WHO 2 or lower - Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity

Exclusion criteria

Exclusion criteria: - Any treatment with investigation drugs within 30 days before the start of the study - Concomitant use of MDR and CYP3A modulating drugs - Unresolved (>grade 1) toxicities of previous chemotherapy - Chronic use of H2-receptor antagonists or proton pump inhibitors - Use of herbal supplements, especially St. John's wort or Echinacea, within 6 weeks prior to study treatment.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters such as AUC, Cmax and t1/2 of docetaxel.	—

Secondary

Measure	Time frame
Adverse events (AE's), serious adverse events (SAE's) and changes in clinical laboratory values.	—

Countries

Europe

Contacts

Public ContactY. Groot

The Netherlands Cancer Institute Scientific Administration

y.groot@nki.nl+81-031205122303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Phase I interaction study of docetaxel with supplementation of St. John&#39;s wort or Echinacea