UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Naoki Nagata
Organization	Kitakyushu General Hospital
Division name	surgery
Address	1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu,
TEL	093-921-0560
Email	n-nagata@kitakyu-hp.or.jp

Public contact
Name of contact person	Yumi Miyashita
Organization	NPO Epidemiological and Clinical Research Information Network (ECRIN)
Division name	Okazaki Office
Address	1-7-9 Hanenishi, Okazaki, Aichi
TEL	0564-64-7300
Homepage URL
Email	miya@ecrin.or.jp

Sponsor
Institute	NPO Epidemiological and Clinical Research Information Network(ECRIN)
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030782