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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007629
Receipt No. R000009003
Scientific Title Pharmacokinetic analysis of docetaxel and dexamethasone in combination with aprepitant in Japanese patients with solid tumors.
Date of disclosure of the study information 2012/04/01
Last modified on 2012/04/04

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Basic information
Public title Pharmacokinetic analysis of docetaxel and dexamethasone in combination with aprepitant in Japanese patients with solid tumors.
Acronym Pharmacokinetic analysis of docetaxel and dexamethasone in combination with aprepitant.
Scientific Title Pharmacokinetic analysis of docetaxel and dexamethasone in combination with aprepitant in Japanese patients with solid tumors.
Scientific Title:Acronym Pharmacokinetic analysis of docetaxel and dexamethasone in combination with aprepitant.
Region
Japan

Condition
Condition cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We analysis the effect on phemacokinetics of docetaxel and dexamethasone, both metabolized by CYP3A4, in combination with antiemetic aprepitant, a substrate and inhibitor of CYP3A4.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To compare intra-patient phamacokinetics of docetaxel and dexamethasone under the three different conditions, which are as follows.

A : without aprepitant.

B1: In combination with aprepitant 3 hours prior to the administration of docetaxel, adjusting timing with Tmax of aprepitant.

B2: In combination with aprepitant 1 hour prior to the administration of docetaxel according to the package insert.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PK study in combination with or without aprepitant.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with histologically or cytologically confirmed solid tumor who are scheduled to receive chemotherapy with docetaxel.

2.Patients with ECOG performance status of 0 to 2.

3.Patients who are 20 years or older.

4.Patients without severe complication, e.g. interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure, incontrollable diabetes or hypertension.

5. The following laboratory conditions within 14 days prior to registration are satisfied.
1) WBC 12000/mm3 or less.
2) neutrophil count 2000/mm3 or higher.
3) Hb 9.0g/dl or higher.
4) platelet count 100.000/mm3 or higher.
5) AST, ALT within 1.5xUNL
6) T.B 1.5mg/dl or less
7) serum Cre within 1.5xUNL

6. Not infected with HCV, HBV or HIV.

7. Patients who gave written informed consent to receive chemotherapy with docetaxel.

8. All patients were asked for written informed consent for their peripheral blood samples and medical research purpose.
Key exclusion criteria 1. Patients with contraindication to docetaxel, involved with bone marrow suppression, active infection, severe hypersensitivity to ingredients contained by docetaxel.

2. Patients with contraindication to aprepitant.

3. Patient with pleural effusion or ascites which should be drainaged.

4. Patients have received chemotherapy including any drug except docetaxel, or radiation therapy within 3 weeks prior to registration.

5. Patients have hormonal therapy within 7 days prior to registration.

6. Women of childbearing potential and men of impregnating potential who don't agree to use adequate contraception, pregnant women, and lactating women.

7. History of severe hypersensitivity to a medicine.

8. Patients with the habit of smoking within one month prior to registration.

9. Patients with any conditions that are unstable or jeopardize the safety of the patient and his/her compliance in the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasutsuna Sasaki
Organization Saitama Medical University, International Medical Center
Division name Department of Medical Oncology
Zip code
Address 1397-1,Yamane, Hidaka city, Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Saitama Medical University, International Medical Center
Division name Department of Medical Oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Saitama Medical University, International Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University, International Medical Center, Department of Medical Oncology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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 03 Month 31 Day
Last modified on
2012 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009003

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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