UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032671 |
|---|---|
| Receipt number | R000037132 |
| Scientific Title | Phase Ib study of combination therapy with Cisplatin, Irinotecan, and Ramucirumab for extensive-disease small-cell lung cancer |
| Date of disclosure of the study information | 2018/05/22 |
| Last modified on | 2021/05/24 13:08:35 |
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Basic information
Public title
Phase Ib study of combination therapy with Cisplatin, Irinotecan, and Ramucirumab for extensive-disease small-cell lung cancer
Acronym
Phase Ib study for SCLC (CIRCLE study)
Scientific Title
Phase Ib study of combination therapy with Cisplatin, Irinotecan, and Ramucirumab for extensive-disease small-cell lung cancer
Scientific Title:Acronym
Phase Ib study for SCLC (CIRCLE study)
Region
| Japan |
Condition
Condition
Extensive disease small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase Ib study of combination therapy with cisplatin, irinotecan, and ramucirumab for extensive-disease small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence rate of dose-limiting toxicities
Key secondary outcomes
Response rate, progression-free survival, overall survival, and incidence rate of adverse events
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
Cisplatin, Irinotecan, Ramucirumab
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Cytologically or histologically confirmed SCLC .
2)Extensive disease
3)Aged 20 to 74 years old
4)ECOG Performance Status 0 or 1
5)No prior chemotherapy for SCLC; however,Patient with postoperative adjuvant chemotherapy history is eligible after more than 6 months.
6)Patients who have not received thoracic radiotherapy with radiation field within the thorax (the lung field and mediastinum).
7)Presence of measurable disease based on RECIST v.1.1; however, irradiated sites are excluded from measurable sites.
8)More than 14 days after the end of palliative radiotherapy in organs other than the chest (the same day of the week can be accepted).
9)Adequate organ functions
10)Life expectancy > 12 weeks.
11)Diarrhea and intestinal obstruction.
12)The patient has resolution to Grade <=1 by CTCAE v.4.0, of any toxic effects of prior anticancer therapy.
13)Women willing not to have children. For women of childbearing potential, serum or urine pregnancy test result during the 7 days prior to the registration must be negative.
14)Written informed consent
Key exclusion criteria
1)Symptomatic brain metastases
2)Major surgery within 28 days or have subcutaneous venous access device placement within 7 days, prior to registration
3)Active infection requiring systemic treatment
4)Body temperature >= 38 degrees Celsius
5)Congestive heart failure with NYHA Class II to IV, or symptomatic, uncontrollable arrhythmia
6)Cirrhosis with Child-Pugh classification B score or more severe, or hepatic encephalopathy history
7)Poorly controlled hypertension
8)Hemoptysis history, more than one-half teaspoonful, within 2 months
9)Vasculitis, grade 3 or above gastrointestinal hemorrhage, or clinically serious hemorrhage within 3 months
10)Gastrointestinal/bowel perforation, gastric ulcer, diverticulum, or fistula within 6 months
11)Poor wound healing or bone fracture within 28 days
12)Radiographic major blood vessel invasion or encasement by cancer
13)Radiographic intratumoral cavitation
14)Active double cancer
15)Myocardial infarction, unstable angina pectoris, cerebrovascular accident, or TIA within 6 months. Any events caused by arterial thromboembolism within 6 months.
16)Receiving long-term treatment of NSAIDS, antiplatelet drug within 7 days before the initial administration of the study drug. Aspirin less than 325mg per day is acceptable.
17)Participant of other clinical studies with other drugs, unapproved drugs and medical devices, or clinical studies that are considered scientifically or medically incompatible with this study
18)Serious hypersensitivity against platinum-based drugs or irinotecan
19)Continuous systemic administration of high-dose steroids equivalent to prednisolone >= 10 mg/day (oral or intravenous), immunosuppressants. Patients who are taking oral steroids equivalent to prednisolone <10 mg/day are acceptable.
20)Interstitial pneumonia, pulmonary fibrosis or severe emphysema
21)Positive HBs antigen
22)Pregnant or lactating women or women willing child-bearing
23)Psychiatric disease
24)The investigator judged ineligible with any reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Takahashi |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
TEL
055-989-5222
circle@scchr.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kenmotsu |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
TEL
055-989-5222
Homepage URL
circle@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
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
Shizuoka Cancer Center Institutional Review Board
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
Tel
055-989-5222
rinsho_office@scchr.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
| 2018 | Year | 05 | Month | 22 | 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
10
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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 22 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037132
