UMIN-ICDS Clinical Trial

Public title

A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer

Acronym

weekly Nab-Paclitaxel+Ramucirumab for unresectable gastric cancer

Scientific Title

A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer

Scientific Title:Acronym

weekly Nab-Paclitaxel+Ramucirumab for unresectable gastric cancer

Region

Japan

Condition

gastric cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of weekly nab-Paclitaxel plus Ramucirumab as 2nd line chemotherapy for unresectable gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Progression-free survival (PFS)

Key secondary outcomes

Overall survival (OS)
Response rate (RR)
Disease control rate (DCR)
Safety (Safety)
Relative dose intensity (RDI)

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

nab-Paclitaxel fixed dose
Ramcirmab fixed dose

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 gastric cancer.
2. Patients resisted first line chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer.
3. Patients with measurable lesions or evaluable lesions within 28 days before registration.
4. Patients with advanced/recurrent gastric cancer which are resistant to first line chemotherapy within 28 days before registration.
5. No influence of prior therapy.
6. PS 0-2
7. Age >=20
8. Expected more than 3 months survival
9. Adequate organ functions (within 14 days before registration)
Leu: >=3,000 /mm3, <=12,000 /mm3
Neu: >= 1,500 /mm3
Plt: >= 100,000 /mm3
Hemoglobin: >= 9.0 g/dL
ALT: <=ULNx2.5
AST: <=ULNx2.5
T-bil: =<1.5mg/dl
Scr: >= 1.5 mg/dl
10. With written informed consent

Key exclusion criteria

1. Patients with serious drug allergy
2. Patients with history of receiving paclitaxel treatment
3. Patients with infectious disease and febrile condition (over 38 centigrade)
4. Patiens with any other serious disease.
5. Patients with history of gastrointestinal perforation and fistula
6. Patients with venous thrombosis and fresh bleeding from intestinal tract.
7. Patients with serious heart disease
8. Presence of active multiple primaries. (Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded.)
9. Patients with peripheral neuropathy(=>Grade2)
10. Patients wit psychological illness
11. Pregnant or nursing female
12. Patient with brain metastasis.
13. Patient with mental illness
14. Not appropriate for the study at the physician's assessment

Target sample size

46

Name of lead principal investigator

1st name
Middle name
Last name	Hiroaki Nagano

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterological, Breast and Endocrine Surgeryy

Zip code

Address

1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Email

hnagano@yamaguchi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Michihisa Iida

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterological, Breast and Endocrine Surgery

Zip code

Address

1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Homepage URL

Email

miida@yamaguchi-u.ac.jp

Institute

Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine

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

2018

Year

02

Month

14

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

Open public recruiting

Date of protocol fixation

2018

Year

02

Month

09

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

13

Day

Last modified on

2018

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035715