UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021107 |
|---|---|
| Receipt number | R000024352 |
| Scientific Title | A phase I/IIa trial of docetaxel plus ribavirin for reprogramming efficacy in patients with progressive metastatic castration resistant prostate cancer who have previously received docetaxel alone |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/12/28 21:07:21 |
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Basic information
Public title
A phase I/IIa trial of docetaxel plus ribavirin for reprogramming efficacy in patients with progressive metastatic castration resistant prostate cancer who have previously received docetaxel alone
Acronym
DRREEM trial
Scientific Title
A phase I/IIa trial of docetaxel plus ribavirin for reprogramming efficacy in patients with progressive metastatic castration resistant prostate cancer who have previously received docetaxel alone
Scientific Title:Acronym
DRREEM trial
Region
| Japan |
Condition
Condition
Docetaxel resistant castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and usefulness of combination therapy with docetaxel and ribavirin for docetaxel-resistant prostate cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidences of adverse events/reactions and their grade
Key secondary outcomes
PSA effects: 30% response rate (>=30% decrease), 50% response rate (>=50% decrease)
Response rate (evaluated according to the RECIST in patients with measurable lesions)
QOL assessment (FACT-P, EQ-5D)
Diagnostic imaging
Blood concentrations of drugs: Changes in the blood concentrations of ribavirin, docetaxel, and prednisolone
Exploratory items: Changes in blood markers(ALP, leptin, IL-1, and IFN-gamma) CTC count and marker expression, blood DNA
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
ribavirin
orally administered twice a day (after breakfast and dinner) for maximum 105 days as following dosage
Body weight:Daily dose
<=60 kg: 600 mg
>60,<=80 kg: 800 mg
>80 kg: 1000 mg
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.Patients aged 30 years or older on obtaining informed consent. However, those (in-/outpatients) aged 75 years or older who are not considered eligible by the chief investigator are excluded.
2.Those with a will to sign the informed consent document who are able to sign it
3.Those histopathologically diagnosed with prostate cancer
4.Those with castration-resistant prostate cancer
5.Those with exacerbation during or after docetaxel therapy
Those with one of the following findings are regarded as showing exacerbation:
1)An increase in the serum PSA level on 2 consecutive blood tests
2)PD evaluated according to the RECIST on diagnostic imaging in patients with measurable lesions
3)Marked enlargement of metastatic foci or appearance of new foci on bone scintigraphy
6.Those who recently received docetaxel therapy
7.Those with a PSA level of more than 2 ng/mL during the screening period
8.Those with no plan of new treatment for prostate cancer during the trial period
9.Those with an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
10.Those whose life expectancy is expected to be more than 12 weeks by the chief investigator or attending physicians
11.Those with favorable blood/liver/kidney functions meeting the following criteria during the screening period
Item:Criterion
Hemoglobin:not less than 11.0 g/dL
AST and ALT:below 60 IU/L
Leukocyte count:not less than 3000/microL
Serum creatinine:not more than 1.5 mg/dL
Neutrophil count:not less than 1500 /microL
Serum potassium:not less than 3.5 mEq
Platelet count:not less than 75000/microL
Serum albumin:not less than 3.0 g/dL
Total bilirubin:not more than 2.5xULN
12.Those consenting to contraception from signing the informed consent document until 6 months after the completion of investigational-drug administration
Key exclusion criteria
1.Patients with a history of hypersensitivity to the components of ribavirin or other antiviral drugs (aciclovir, ganciclovir, or vidarabine) who are not considered eligible by the chief investigator
2.Those who are to receive aciclovir or paclitaxel within 7 days before the start of investigational-drug administration
3.Those with serious complications other than prostate cancer on obtaining informed consent
4.Those with double cancer in whom the interval from previous treatment is <5 years on obtaining informed consent
5.Those participating in another trial on obtaining informed consent
6.Those receiving cabazitaxel
7.Others who are not considered eligible by the chief investigator or attending physicians
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeo Kosaka |
Organization
Department of Urology,Keio University School of Medicine
Division name
Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL
03-3353-1211
takemduro@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Saito |
Organization
Keio University Hospital
Division name
Clinical and Translational Research Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL
03-5315-4278
Homepage URL
pmo@ccr.med.keio.ac.jp
Sponsor or person
Institute
Department of Urology,Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2016 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024352
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
