UMIN-CTR Clinical Trial

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

cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Saitama Medical University, International Medical Center

Institute

Department

Personal name

Organization

Saitama Medical University, International Medical Center, Department of Medical Oncology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

03

Month

31

Day

Last modified on

2012

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009003