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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018968
Receipt No. R000021872
Scientific Title Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy
Date of disclosure of the study information 2015/09/10
Last modified on 2020/09/14

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Basic information
Public title Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy
Acronym Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy
Scientific Title Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy
Scientific Title:Acronym Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy
Region
Japan

Condition
Condition unresectable metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of regorafenib 120mg as salvage-line treatment in patients with metastatic colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease control rate
Key secondary outcomes Overall survival, Progression free survival, Response rate, Safety, Drug compliance (Dose intensity)

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 Regorafenib 40 mg tablets
Regorafenib 120 mg od po. 3weeks on/1 week off
Patients will continue study treatment until disease progression
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)Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent.
2) Male or female patients >= 20
3) Historical or cytological documentation of adenocarcinoma of the colon or rectum
4) Progress during or within 3 month following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab.
5) Patients must have measurable or non measurable disease according to RECIST version 1.1
6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
7) Life expectancy of at least 3 months.
8) Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements conducted within 14 days of starting study treatment:
1. Absolute neutrophil count >= 1500 /mm3
2. Hemoglobin >= 9.0 g/dl
3. Platelet >=100000 /mm3
4. Total bilirubin <=1.5 ml/dl
5. AST and ALT <=150 IU/l
6. Creatinine <= 1.5 mg/dl
Key exclusion criteria 1) Prior treatment with regorafenib.
2) Previous or concurrent cancer that is distinct in primary site or histology form colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervicalcancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta, Tis and T1].
3) Major surgical procedure within 28 days before start of study medication.
4) Pregnant or breast-feeding patients. Woman of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
5)Congestive heart failure >=NYHA class 2.
6) Unstable angina, new-onset angina. Myocardial infarction less than 6 months before start of study medication.
7)Uncontrolled hypertension.
8) Pleural effusion or ascites with dyspnea higher than CTCAE v4.0 grade 2.
9) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
10) Known history of HIV infection, or chronic hepatitis B or C.
12) Symptomatic metastatic brain or meningeal metastasis.
13) Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE v4.0 Grade 3 within 4 weeks of start of study medication.
14) Interstitial lung disease with ongoing sings and symptoms at the time of informed consent.
15) Persistant proteinuria of CTCAE v4.0 Grade 3 or higher.
16) Patients unable to swallow oral medications.
17) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
18) Non-healing wound, ulcer, or bone fracture.
19) Unsolved toxicity higher than CTCAE v4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity <= Grade 2
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Toshihiro
Middle name
Last name Kudo
Organization Graduate School of Medicine Osaka University
Division name Department of Frontier Science for Cancer and Chemotherapy
Zip code 565-0871
Address E21-19, 2-2 Yamadaoka Suita, Osaka Japan
TEL 06-6879-2641
Email tkudo@cfs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Toshihiro
Middle name
Last name Kudo
Organization Graduate School of Medicine Osaka University
Division name Department of Frontier Science for Cancer and Chemotherapy
Zip code 565-0871
Address E21-19, 2-2 Yamadaoka Suita, Osaka Japan
TEL 06-6879-2641
Homepage URL
Email tkudo@cfs.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization Bayer Yakuhin, 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 Independent Ethics Committee, Osaka University
Address The Center of Medical Innovation and Translational Research 4F, 2-2 Yamadaoka Suita, Osaka Japan
Tel 06-6210-8290
Email shiken@hp-crc.med.osaka-u.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
2015 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2015 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 14 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
2015 Year 09 Month 10 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021872

Research Plan
Registered date File name
2016/10/19 Reg120_最新プロトコール等.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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