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

Extensive disease small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

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

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

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

Email

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

Email

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

Email

rinsho_office@scchr.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name