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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030614
Receipt No. R000034961
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
Date of disclosure of the study information 2017/12/30
Last modified on 2019/06/30

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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/ctr_e/ctr_view.cgi?recptno=R000034961

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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