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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004470 |
Receipt No. | R000005309 |
Scientific Title | Microdosing study with docetaxel: Clinical pharmacology and pharmacogenetic exploratory research |
Date of disclosure of the study information | 2010/10/28 |
Last modified on | 2012/05/01 |
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 |
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Condition | ||
Condition | Cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama Medical University, International Medical Center | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 1397-1, Yamane, Hidaka city, Saitama | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | Saitama Medical University, International Medical Center | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | |||||||
TEL | 042-984-4679 | ||||||
Homepage URL | |||||||
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 | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |