UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021949
Receipt number R000025174
Scientific Title A phase I trial of biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Date of disclosure of the study information 2016/05/23
Last modified on 2016/04/08 12:32:39

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Basic information

Public title

A phase I trial of biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer

Acronym

Biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer

Scientific Title

A phase I trial of biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer

Scientific Title:Acronym

Biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer

Region

Japan


Condition

Condition

metastatic or recurrent gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The sefety of nab-paclitaxel plus ramucirumab combination as second line therapy in patients with advanced gastric cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Maximum tolerated dose, recommended dose

Key secondary outcomes

adverse events, overall response rate, disease control rate


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

Nab-paclitaxel is administered 100mg/m2 given intravenously in a 2-week cycle. Ramurcirumab is administered 8mg per body weight intravenously in a 2-week cycle.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)written informed consent got from the patient
2)patient who has histologically or cytologically confirmed gastric adenocarcinoma
3)patient who previously treated with fluorouracil regimens for advanced gastric cancer, and who is refractory or intolerant to them
4)patient with an ECOG Performance Status of between 0 and 1
5)patient is >=20 years old and <80 years old
6)patient who has a life expectancy of at least 90 days
7)patient who has adequate main organ functions in tests within 2 weeks before enrollment
a)haemoglobin concentorarion >=8.0 g/dL
b)white blood cell(WBC) count >=3,000/mm3 or neutrophil count >=1,500/mm3, and WBC count <=12,000/mm3
c)platelet count >=100,000/mm3
d)serum total bilirubin level <=one and a half times as many as average level baseline
e)serum AST and ALT levels two and a half times as many as average level baseline
f)serum creatinine <=1.5 mg/dL

Key exclusion criteria

1)patient with allergy of paclitaxel or ramucirumab
2)patient with contraindication for paclitaxel or ramucirumab
3)patient who had previously administered with paclitaxel as first line therapy
4)patient who has a serious infection
5)patient who has serious complications such as heart disease, respitary disorder, cerebrovascular disorder, liver disease and much ascites or pleural effusion
6)patient who has recieved chemotherapy within 2weeks
7)patient who has recieved therapy with blood products
8)patient with other malignat tumor
9)patient with neuropathy (>=grade 2)
10)patient with urinary protein (>=grade 2)
11)patient with brain symptomatic metastasis
12)patient who recieved with steroid
13)patient with psychic disorder
14)patient with pregnancy, lactating or possibility of pregnancy
15)patient who given a dicision of unsuitable for this study by the investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuji Takayama

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School

Division name

Gastroenterology and Oncology

Zip code


Address

3-18-15 Kuramoto Tokushima-city, Tokushima Japan

TEL

088-633-7124

Email

takayama@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuji Takayama

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School

Division name

Gastroenterology and Oncology

Zip code


Address

3-18-15 Kuramoto Tokushima-city, Tokushima Japan

TEL

088-633-7124

Homepage URL


Email

takayama@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization


Address


Tel


Email



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

徳島大学病院(徳島県)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 23 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

Preinitiation

Date of protocol fixation

2016 Year 05 Month 23 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 17 Day

Last modified on

2016 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name