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
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
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
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
