UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018968 |
|---|---|
| Receipt number | 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 | 2023/04/10 12:55:05 |
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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
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
tkudo@cfs.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
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
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
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 10 | Day |
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
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021872
