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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036158
Receipt No. 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 2019/03/11

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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 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
Email 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
Email mfukudo@asahikawa-med.ac.jp

Sponsor
Institute Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University
Institute
Department

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
Email 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 Open public recruiting
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

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
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041195

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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