UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation of the tolerability of Nab-paclitaxel (Nab-PTX) + Ramucirumab combination therapy in unresectable progressive / recurrent gastric cancer secondary therapy Phase I / II trial
Acronym	Tolerability confirmation test of Nab-paclitaxel (Nab-PTX) + Ramucirumab combination therapy in advanced / recurrent gastric cancer secondary treatment
Scientific Title	Confirmation of the tolerability of Nab-paclitaxel (Nab-PTX) + Ramucirumab combination therapy in unresectable progressive / recurrent gastric cancer secondary therapy Phase I / II trial
Scientific Title:Acronym	Tolerability confirmation test of Nab-paclitaxel (Nab-PTX) + Ramucirumab combination therapy in advanced / recurrent gastric cancer secondary treatment
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In the unresectable progressive / recurrent gastric cancer secondary therapy, tolerability of Nab-paclitaxel (Nab-PTX) + Ramucirumab combination therapy will be examined. "Phase I part" Main endpoint: Determination of recommended dose (RD) for combination therapy with Nab-PTX + Ramucirumab "Phase II part" Primary endpoint: treatment completion ratio at 12 weeks after starting administration
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	"Phase I part": Determination of recommended dose (RD) for combination therapy with Nab-PTX + Ramucirumab
Key secondary outcomes	"Phase II part" Primary endpoint: treatment completion ratio at 12 weeks after starting administration

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Case of gastric cancer confirmed to be adenocarcinoma by histology or cytology. (2) Patients with age at registration of 20 years or older. (3) Case in which ECOG PS is 0 or 1. (4) Case of unresectable progressive/recurrent gastric cancer. (5) Case in which exacerbation/new lesion or recurrence was observed in the primary chemotherapy containing 5-FU drug against unresectable progressive/recurrent gastric cancer or within 16 weeks from the final administration day. (6) or cases in which recurrence was observed in the image during adjuvant chemotherapy or within 24 weeks from the last administration day. (7) A case in which adverse events due to pretreatment have recovered to CTCAE Grade 1 or lower. (8) Cases in which major organ functions are retained by clinical examination within 14 days before registration (inspection on the same day two weeks before registration date is acceptable). 1.Wte blood cell count: lower limit of facility reference value or 4,000/mm 3 or more and 12,000/mm 3 or less 2. Number of neutrophils: 2,000/ mm 3 or more 3. Platelet count: 100,000/mm 3 or more 4. Hemoglobin: 9.0 g /dL or more 5. Bilirubin in the blood: 1.5 mg/dL or less 6.AST: Standard upper limit value of medical institutions to be administered x 2.5 times or less 7. ALT: Standard limit value of medical institutions under implementationx2.5 times or less 8. Serum creatinine: 1.5 mg/ dL or less 9.reatinine clearance: 50 mL/ min or more
Key exclusion criteria	(1) Cases of squamous cell carcinoma, undifferentiated gastric cancer. (2) Consent Acknowledgment cases that underwent major surgery within 28 days before acquisition (3) Case in which chemotherapy other than platinum drugs and 5-FU drugs was administered to nonresectable progressive/recurrent gastric cancer (4) Patients who have undergone systemic chemotherapy that targeted the VEGF or VEGFR signaling pathway in the past. (5) Consent Acknowledgment cases with deep vein thrombosis, pulmonary embolism, or other serious thromboembolic disorder within 3 months before acquisition. (6) Cases receiving anticoagulant therapy such as warfarin, low molecular weight heparin (7) Cases receiving long-term administration of nonsteroidal anti-inflammatory drugs or other antiplatelet drugs (8) A patient with serious bleeding disorder or vasculitis, (9) Consent Acknowledgment cases with gastrointestinal perforation and/or fistulas within 6 months before acquisition. (10) Patients with symptomatic congestive heart failure or symptomatic or uncontrolled arrhythmia. (11) Cases with a history of arterial thromboembolism-related events, (12) Cases with arterial hypertension that can not be controlled despite standard medical management. (13) Cases with serious or unrecovered wounds, a history of peptic ulcer or bone fracture within 28 days before consent acquisition. (14) Cases with intestinal obstruction, cases with a history or complication of inflammatory bowel disease or extensive intestinal resection (15) Cases that have been treated with investigational drugs within 28 days before acquisition or scheduled to be treated with investigational drugs in the future. (16) Cases in which there is a schedule of treatment using drugs prohibited for use in this study at the time of consent acquisition. (17) Cases during pregnancy or lactation.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Tanaka
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Surgical Oncology,
Zip code	545-8585
Address	1-4-3, Asahimachi, Abenoku, Osaka
TEL	06-6645-3838
Email	hiroakitan@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Tanaka
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Surgical Oncology,
Zip code	545-8585
Address	1-4-3, Asahimachi, Abenoku, Osaka
TEL	06-6645-3838
Homepage URL
Email	hiroakitan@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgical Oncology, Osaka City University Graduate 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	Osaka City University Hospital Certified Review Board
Address	1-4-3, Asahimachi, Abenoku, Osaka
Tel	06-6645-3456
Email	ethics@med.osaka-cu.ac.jp

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	大阪市立大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 12 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	Preinitiation
Date of protocol fixation	2017 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date	2017 Year 12 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2017 Year 12 Month 28 Day
Last modified on	2019 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034961