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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014873
Receipt No. 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

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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
Institute Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology
Institute
Department

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
URL(English) https://upload.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


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