UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036158 |
|---|---|
| Receipt number | R000041195 |
| Scientific Title | An exploratory study of PRecision dOsing of moLecular targeted agents based On therapeutic drug monitoriNG |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2020/04/30 16:08:17 |
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Basic information
Public title
An exploratory study of PRecision dOsing of moLecular targeted agents based On therapeutic drug monitoriNG
Acronym
PROLONG study
Scientific Title
An exploratory study of PRecision dOsing of moLecular targeted agents based On therapeutic drug monitoriNG
Scientific Title:Acronym
PROLONG study
Region
| Japan |
Condition
Condition
1) Colorectal cancer
2) Gastrointestinal stromal tumors
3) Hepatocellular carcinoma
4) Renal cell carcinoma
5) Soft tissue sarcoma
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Orthopedics | Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We will reveal the clinical usefulness of pharmacokinetically (PK)-guided dosing strategy of molecular targeted agents (regorafenib, pazopanib, and axitinib) in the determination of a tolerable maintenance dose for prolonged duration of treatment in advanced cancer patients. In addition, we will explore associations between drug exposure and clinical efficacy and safety. Furthermore, we will clarify the impact of genetic polymorphisms on the interindividual variability in plasma and urine drug concentrations.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To reveal the clinical benefit of therapeutic drug monitoring (TDM) of molecular targeted agents (regorafenib, pazopanib, and axitinib) in terms of prolonged duration of treatment by determining a tolerable maintenance dose in individual patients, compared with the empirical approach based only on clinical and laboratory findings.
Key secondary outcomes
1) To explore associations between drug exposure and clinical efficacy and safety.
2) To clarify the impact of genetic polymorphisms on the interindividual variability in plasma and urine drug concentrations.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) PK profiles of regorafenib and its metabolites (M-2/M-5 and M-7/M-8) at week 1, 2, and 3 during the first cycle will be examined. In addition, the subsequent drug concentrations after dose adaptation by taking individual drug concentration and the target trough level (1400 ng/mL) into consideration will be evaluated.
2) PK profile of pazopanib at steady state after start of treatment will be examined. In addition, the subsequent drug concentrations after dose adaptation by taking individual drug concentration and the target trough level (20.5 mcg/mL) into consideration will be evaluated.
3) PK profile of axitinib at steady state after start of treatment will be examined. In addition, the subsequent drug concentrations after dose adaptation by taking individual drug concentration and historical PK data into consideration will be evaluated.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) All patients treated with regorafenib
2) All patients treated with pazopanib
3) All patients treated with axitinib
4) Patients who can give written informed consent
Key exclusion criteria
1) Patients who are currently participating in or will be enrolled in clinical trials
2) Patients receiving molecular targeted therapy as an off-label use
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Fukudo |
Organization
Asahikawa Medical University
Division name
Department of Hospital Pharmacy and Pharmacology
Zip code
078-8510
Address
2-1-1-1 Midorigaokahigashi, Asahikawa 078-8510, Japan
TEL
0166-69-3482
mfukudo@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Fukudo |
Organization
Asahikawa Medical University
Division name
Department of Hospital Pharmacy and Pharmacology
Zip code
078-8510
Address
2-1-1-1 Midorigaokahigashi, Asahikawa 078-8510, Japan
TEL
0166-69-3482
Homepage URL
mfukudo@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaokahigashi, Asahikawa 078-8510, Japan
Tel
0166-68-2297
rs-kk.g@asahikawa-med.ac.jp
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
| 2019 | Year | 03 | Month | 11 | 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 | 05 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Outcome measures to be studied:
1) Objective response rate
2) Progression-free survival
3) Overall survival
4) Duration of treatment
5) Frequency of adverse events
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041195
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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