UMIN-CTR Clinical Trial

Public title

Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer

Acronym

Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer

Scientific Title

Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer

Scientific Title:Acronym

Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer

Region

Japan

Condition

chemo-refractory gastric cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study will evaluate the efficacy of combination therapy with ramucirumab and irinotecan in patients with advanced chemo-refractory gastric cancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

DLTs

Key secondary outcomes

progression-free survival, time to treatment failure, response rate, disease control rate, adverse events, relative dose intensity

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ramucirumab:
8 mg/kg, day1, biweekly

Irinotecan:
150 mg/m2, day1, biweekly

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histopathologically confirmed adenocarcinoma of gastric or gastroesophageal junction (GEJ) with inoperable, locally advanced or metastatic disease, not amenable to curative therapy.
2. Documented objective radiographic or clinical disease progression after chemotherapy.
3. Measurable disease or non-measurable but evaluable disease, according to RECIST criteria version 1.1.
4. Age >= 20 years.
5. ECOG PS of 0 or 1.
6. Sufficient oral intake.
7. Adequate organ function.
8. Life expectancy of at leaset 3 months.
9. Written informed consent obtained prior to any study specific procedures.

Key exclusion criteria

1. History of another malignancy which could affect compliance with the protocol or interpretation of result of the study.
2. Previous systemic chemotherapy with irinotecan.
3. Uncontrolled arterial hypertension (e.g. >= 150 / >= 90 mmHg despite standard medical management)
4. Active infection requiring intravenous antibiotics at entry.
5. Serious illness or medical conditions.
6. Uncontrolled diarrhea which disrupt daily life despite fully medical management.
7. History of severe allergy or hypersensitivity for any drugs.
8. Moderate or large ascites or pleural effusion.
9. Chronic daily treatment with oral cortisteroid treatment.
10. Evidence of psychological disorder.
11. Symptomatic evidence of known central nervous system metastases or carcinomatous meningitis.
12. Daily treatment with atazanavir sulfate.
13. Pregnant or breastfeeding, or unwilling to practice contraception during the study.
14. Known acute or choric-active infection with HBV or HCV.
15. Any condition that suggest that the patient is, in the investigator's opinion, not an appropriate candidate for the study.

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Taroh Satoh

Organization

Osaka Univesity

Division name

Department of Frontier Science for Cancer and Chemotherapy

Zip code

Address

2-2, Yamadaoka, Suita, Osaka, JAPAN

TEL

06-6879-5111

Email

taroh@cfs.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Daisuke Sakai

Organization

Osaka Univesity

Division name

Department of Frontier Science for Cancer and Chemotherapy

Zip code

Address

2-2, Yamadaoka, Suita, Osaka, JAPAN

TEL

06-6879-5111

Homepage URL

Email

dsakai@cfs.med.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2015

Year

09

Month

19

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

19

Day

Last modified on

2018

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022054