UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gatroenterology and Hepatology
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	Takeshi Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Gatroenterology and Hepatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016811