UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014873
Receipt number R000016811
Scientific Title Phase1/2 study of nab-Paclitaxel + trastuzumab therapy in 2nd line treatment for HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.
Date of disclosure of the study information 2014/09/01
Last modified on 2018/09/10 18:11:58

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Basic information

Public title

Phase1/2 study of nab-Paclitaxel + trastuzumab therapy in 2nd line treatment for HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.

Acronym

Phase 1/2 study to assess the the safety of nab-Paclitaxel + trastuzumab therapy and the concept of using trastuzumab beyond progression

Scientific Title

Phase1/2 study of nab-Paclitaxel + trastuzumab therapy in 2nd line treatment for HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.

Scientific Title:Acronym

Phase 1/2 study to assess the the safety of nab-Paclitaxel + trastuzumab therapy and the concept of using trastuzumab beyond progression

Region

Japan


Condition

Condition

HER2-positive gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Phase 1: To know the feasibility and recommended dose of nab-Paclitaxel + trastuzumab.
Phase 2: The effectivemess and safety at recommended dose

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Phase 1: Maximum tolerated dose and recommended dose
Phase 2: Response rate (RR)

Key secondary outcomes

Phase 1: Response rate(RR), incidence and degree of adverse events
Phase 2: Progression free survival (PFS), Overall survival (OS), Incidence 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

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Trastuzumab: 8mg/kg(i.v.) for the initial dosing and 6mg/kg for subsequent administration at day 1
nab-Paclitaxel: 180-260mg/m2 administration at day 1 (dose escalation: level 0 - 180mg/m2,level 1 = 220mg/m2, level 2 = 260mg/m2)

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. Histological confirmed unresectable advanced or recurrent gastric cancer
2. Positive HER2 status (IHC3+ or IHC2+/FISH+)
3. Age over 20 years old
4. Cases with measurable lesion
5. No previous chemotherapy or radiation therapy for malignant tumor except for gastric cancer
6. Refractory to fluoropyrimidine, platinum and trastuzumab containing chemotherapy
7. Prior trastuzumab therapy with more than three doses, and within 6 weeks from last trastuzumab administration
8. No prior therapy with taxan
9. No prior therapy with anti-HER2 drugs except trastuzumab
10. No clinical ileus or subileus
11. ECOG performance status 0-2
12.Cases expected to survive for 90 days or more
13. Cases with adequately maintained organ functions and fullfilling the following conditions within 2 weeks before registration.
leukocyte count <= 12000/mm3
neutrophil count >= 1,500/ mm3
hemoglobin level >= 8.0g/ dL
platelet count >= 75,000/mm3
AST and ALT <= 100IU/L, or AST and ALT <= 200IU/L with liver metastases
total bilirbin <= 1.5mg/dL
serum creatinine <= 1.5mg/dL
14. Left ventricular ejection fraction (LVEF) >= 50% measured by echocardiography or multi-gated acquisition scan (MUGA)
15. Written informed consent

Key exclusion criteria

1. Discontinuation of tratuzumab due to adverse event
2. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma
3. Evidence of any other serious disease
4. Active local or systemic infection under treatment
5. History of serious allergic reaction
6. Pulmonary fibrosis or interstitial pneumonitis detected by chest X-ray
7. Symptomatic brain metastases or carcinomatous meningitis
8. Massive pericardial effusion, pleural effusion or ascites
9. Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0
10. Pregnant or lactating female
11. Judged inappropriate by the investigators

Target sample size

23


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gatroenterology and Hepatology

Zip code


Address

465 Kaji-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Gatroenterology and Hepatology

Zip code


Address

465 Kaji-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

iskw-t@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyoto City Hospital, Department of Gastroenterology

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

京都府立医科大学附属病院(京都府)、京都市立病院(京都府)


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 01 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

Terminated

Date of protocol fixation

2014 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 06 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

2014 Year 08 Month 16 Day

Last modified on

2018 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016811


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name