UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026817 |
|---|---|
| Receipt number | R000030782 |
| Scientific Title | A Multicenter single arm Phase II clinical trial of the second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special reference to the changes in biomarker expression examined by a liquid biopsy and its effect on the refractory tumor |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2018/08/06 12:03:40 |
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Basic information
Public title
A Multicenter single arm Phase II clinical trial of the second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special reference to the changes in biomarker expression examined by a liquid biopsy and its effect on the refractory tumor
Acronym
PBP (Panitumumab beyond Progression)
Scientific Title
A Multicenter single arm Phase II clinical trial of the second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special reference to the changes in biomarker expression examined by a liquid biopsy and its effect on the refractory tumor
Scientific Title:Acronym
PBP (Panitumumab beyond Progression)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effect of FOLFIRI with panitumumab as the second-line therapy in patient with RAS wild-type advanced and metastatic colorectal cancer, with additional evaluation of clonal evolution and resistance to anti-EGFR treatment through circulating tumor DNA (ctDNA) examined by liquid chromatography tests.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-month progression-free survival (PFS) rate *
Key secondary outcomes
Overall survival (OS)
Progression-free survival (PFS)**
Time to treatment failure (TTF)
Overall response rate (ORR)
Disease control rate (DCR)
Relative dose intensity (RDI)
Safety and tolerability
Gene mutation status
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
Second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special reference to the changes in biomarker expression examined by a liquid biopsy and its effect on the refractory tumor
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) Histologically-confirmed inoperable colorectal adenocarcinoma
2) Age more than 20 years
3) ECOG performance status of 0-2
4) Written informed consent prior to study-specific screening procedures
5) Life expectancy of at least 90 days
6) Withdrawal from the first-line chemotherapy with FOLFOX + panitumumab for RAS wild-type advanced or metastatic colorectal cancer due to intolerable toxicity or progressive disease
7) Adequate organ function
Key exclusion criteria
1) History of other malignancy with a disease-free interval <5 years
2) With massive pleural effusion or ascites requiring intervention
3) Radiological evidence of brain tumor or brain metastases
4) Active infection including hepatitis
5) Any of the following complication:
i) Gastrointestinal bleeding or gastrointestinal obstruction
ii) Symptomatic heart disease
iii) Interstitial pneumonia or pulmonary fibrosis
iv) Uncontrolled diabetes mellitus
v) Uncontrolled diarrhea
6) Any of the following medical history:
i) Myocardial infarction
ii) Serious hypersensitivity
iii) History of adverse reaction to fluoropyrimidines
iv) Previous treatment with irinotecan hydrochloride
v) Current treatment with atazanavir sulfate
vi) Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment
vii) Pregnant and lactating females
viii) Requires continuous treatment with systemic steroids
ix) Psychiatric disability
x) unsuitable for participation in the study
xi) History of pulmonary hemorrhage/hemoptysis more than Grade 2
xii) History of laparotomy, thoracotomy, or intestinal resection within 28 days
xiii) Unhealed wound
xiv) Current or recent (within 1 year) thromboembolism or cerebrovascular disease
xv) Currently receiving or requires anticoagulation therapy (more than 325 mg/day of aspirin)
xvi) Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR more than 1.5 within 14 days before enrollment)xvii) Uncontrolled hypertension
xviii) Urine dipstick for proteinuria more than +2
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Nagata |
Organization
Kitakyushu General Hospital
Division name
surgery
Zip code
Address
1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu,
TEL
093-921-0560
n-nagata@kitakyu-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Miyashita |
Organization
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Division name
Okazaki Office
Zip code
Address
1-7-9 Hanenishi, Okazaki, Aichi
TEL
0564-64-7300
Homepage URL
miya@ecrin.or.jp
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network(ECRIN)
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 03 | Month | 31 | 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
| 2017 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | 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
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030782
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