UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009427 |
|---|---|
| Receipt number | R000011075 |
| Scientific Title | Phase I interaction study of docetaxel with supplementation of St. John's wort or Echinacea |
| Date of disclosure of the study information | 2012/11/29 |
| Last modified on | 2012/11/29 00:54:43 |
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Basic information
Public title
Phase I interaction study of docetaxel with supplementation of St. John's wort or Echinacea
Acronym
Interaction study of docetaxel and St. John's wort or Echinacea
Scientific Title
Phase I interaction study of docetaxel with supplementation of St. John's wort or Echinacea
Scientific Title:Acronym
Interaction study of docetaxel and St. John's wort or Echinacea
Region
| Europe |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine pharmacokinetic interactions between St. John's wort and docetaxel and between Echinacea and docetaxel in patients with cancer.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Pharmacokinetic parameters such as AUC, Cmax and t1/2 of docetaxel.
Key secondary outcomes
Adverse events (AE's), serious adverse events (SAE's) and changes in clinical laboratory values.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine | Other |
Interventions/Control_1
Docetaxel + Echinacea
Interventions/Control_2
Docetaxel + St. John's wort
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key 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
Key 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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. J.H.M. Schellens, MD, PhD |
Organization
The Netherlands Cancer Institute
Division name
Department of Clinical Pharmacology
Zip code
Address
Plesmanlaan 121, 1066 CX, Amsterdam
TEL
+81-031205122446
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Y. Groot |
Organization
The Netherlands Cancer Institute
Division name
Scientific Administration
Zip code
Address
Plesmanlaan 121, 1066 CX, Amsterdam
TEL
+81-031205122303
Homepage URL
y.groot@nki.nl
Sponsor or person
Institute
The Netherlands Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Dutch Cancer Society
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
The Netherlands
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
The Netherlands Cancer Insitute
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 29 | Day |
Last modified on
| 2012 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011075
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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