UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011882
Receipt number R000013825
Scientific Title Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Date of disclosure of the study information 2013/09/30
Last modified on 2018/10/02 17:20:56

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Basic information

Public title

Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy

Acronym

Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy

Scientific Title

Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy

Scientific Title:Acronym

Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy

Region

Japan


Condition

Condition

Advanced Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of weekly Nab paclitaxel advanced advanced for gastric cancer patients with prior chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Incidence and grade of Adverse Event, Response Rate,Over all Survival


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(80mg/m2 day1,8,15) every 4 weeks

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who provided written informed consent.
2.Patients with gastric cancer by histological or cytological examination.
3.Patients with prior on chemothrapy.
(including recurrence within 6 months after last adjuvant chemotherapy)
4.More than 2 weeks last chemotherapy
5.ECOG performance status<=2
6.Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration
WBC count more than 3,000/mm3
Neutrophils count more than 1,200/mm3
Hemoglobin more than 8.0 g/dl
Platelet count more than 75,000/mm3
Serum bilirubin level less than 2.0mg/dl
AST and ALT less than 100 IU/l
20 years old or more
Patients expected to survive for 90 more than days

Key exclusion criteria

1.History of serious drug hypersensitivity
2.Any other serious illness or medical conditions including interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure,cerebrovascular disordar or Uncontrolled diabates
3.Active infection or fever suspicious of infection.
4.Surgical procedure within 4 weeks before registration
5.Uncontrolled unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia
6.History of mental disorder, central nerve disorder.
7.Pregnant women, nursing mothers
8.Patients who were considered by the primary care physician to be inappropriate for this trial

Target sample size

21


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryoji Fukushima

Organization

Teikyo University School of Medicine

Division name

Surgery

Zip code


Address

2-11-1 Kaga, Itabashi-ku Tokyo

TEL

03-3964-1231

Email

ryojif@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryoji Fukushima

Organization

Teikyo University School of Medicine

Division name

Surgery

Zip code


Address

2-11-1 Kaga, Itabashi-ku Tokyo

TEL

03-3964-1231

Homepage URL


Email

ryojif@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Teikyo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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

帝京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 30 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

2013 Year 08 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 20 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

2013 Year 09 Month 27 Day

Last modified on

2018 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name