UMIN-CTR Clinical Trial

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

Objectives
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

Assessment
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

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	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

Eligibility
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

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	042-984-4679
Homepage URL
Email

Sponsor
Institute	Saitama Medical University, International Medical Center, Department of Medical Oncology
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	Tokyo University, Graduate School of Pharmaceutical Sciences, Department of Molecular Pharmacokinetics
Name of secondary funder(s)	Association for Promoting Drug Development

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	2010 Year 10 Month 28 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	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
Other related information

Management information
Registered date	2010 Year 10 Month 28 Day
Last modified on	2012 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005309

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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