UMIN-CTR Clinical Trial

Public title

Microdosing study with docetaxel: Clinical pharmacology and pharmacogenetic exploratory research

Acronym

Microdosing study with docetaxel

Scientific Title

Microdosing study with docetaxel: Clinical pharmacology and pharmacogenetic exploratory research

Scientific Title:Acronym

Microdosing study with docetaxel

Region

Japan

Condition

Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

We exploratory evaluate the possibility of microdosing in developing new anticancer drugs by following the Japanese guidance of microdosing. We adopt docetaxel as an anticancer drug which was already approved by Military of Health, Labor and Welfare. Microdosing followed by standard dosing are given to Japanese patients with cancer.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To compare pharmacokinetics of docetaxel seen after the microdosing with those observed after the standard dosing in patients with tumor

Key secondary outcomes

Pharmacogenetic analysis for factors responsible for the metabolism or transport of docetaxel

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

Microdosing, standard dosing

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 confirmed solid tumors.
2)Patients who are candidates of docetaxel treatment.
3)Patients with breast cancer, non-small cell lung cancer, stomach cancer, head and neck cancer, esophargus cancer, ovarian cancer or uterine body cancer that are approved by Miritary of Health, Labor and Wealfare to be treated with docetaxel. Patients with adenoid cystic carcinoma, carcinoid, unknown primary tumor or soft tissue sarcoma which are not proved the no effects of docetaxel.
4)Patients with unresectable, locally advanced, metastatic or recurrent tumor.
5)Patients with measurable and evaluable lesion(s).
6)Patients who are 20 years or higher.
7)Patients with ECOG performance status of 0 to 2.
8)Patients who are expected to live at least 3 months or more.
9)No history of chemotherapy, hormonetherapy or molecularly targeted therapy within 3 weeks.
10)No history of radiotherapy within 2 weeks
11)Patients with adequate organ functions.
12)Inclusion criteria observed within 1 week.
1. WBC count 1000 /mm3 or higher.
2. Neutrophil count 1500 /mm3 or higher.
3. Platelet count 100,000 /mm3 or higher.
3. Hemoglobin 9.0 g/dL or higher.
4. AST, ALT less than 2.0 times the upper limit of normal.
5. Total bilirubin 2.0 mg/dL or less.
6. AST, ALT less than twice as high as upper limit of normal
7. Serum creatinine 1.2 mg/dLor less.
8. Creatinine clearance 60 mL/min or higher (Cockcroft-Gault equation)
13)All patients were asked for written informed consent for their
peripheral blood samples and medical information to be used for
research purposes.

Key exclusion criteria

1)Patients with severe allergy or those who had severe allergy in the past (including that for polysorbate 80).
2)Pregnant patients. Men and women who want to make baby.
3)Ptisnts with active infection. HCV, HBs or HIV positive.
4)Patients with severe complications (interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure, incontrollable diabetes or hypertension).
5)Patients with cardiovascular disease or showing severely atypical electro cardiogram.
6)Patients with gastrointestinal ulcer or related bleeding.
7)Patients with uncontrollable diarrhea.
8)Patients with brain metastasis with any symptoms or those without any symptoms with steroid medication.
9)Patients with pleural fluid or abdominal dropsy which is required medical intervention.
10)Patients who experienced thromboembolism, stroke or pulmonary infarction.
11)Patients who receive operation within 28 days.
12)Patients with inborn hemorrhagic diathesis, coagulation disorder or those with DIC.
13)Patients having anticoagulant including aspirin or warfarin.
14)Patients with continuous steroid therapy.
15)Patients who do not understand this study well.
16)Patients who are not appropriate to participate in the study safely.

Target sample size

10

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

042-984-4679

Homepage URL

Email

Institute

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

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

Tokyo University, Graduate School of Pharmaceutical Sciences, Department of Molecular Pharmacokinetics

Name of secondary funder(s)

Association for Promoting Drug Development

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

2010

Year

10

Month

28

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

Completed

Date of protocol fixation

2010

Year

10

Month

22

Day

Date of IRB

Anticipated trial start date

2010

Year

11

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

2010

Year

10

Month

28

Day

Last modified on

2012

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005309