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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020579
Receipt No. R000023554
Scientific Title An open label, non-randomized phase I/II study of ramucirumab in combination with nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
Date of disclosure of the study information 2016/01/15
Last modified on 2019/07/22

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Basic information
Public title An open label, non-randomized phase I/II study of ramucirumab in combination with nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
Acronym A phase I/II study of ramucirumab plus nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
Scientific Title An open label, non-randomized phase I/II study of ramucirumab in combination with nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
Scientific Title:Acronym A phase I/II study of ramucirumab plus nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I part: To determine the maximum tolerated dose (MTD) and recommended dose (RD)of ramucirumab plus nab-PTX in patients with advanced gastric cancer.
Phase II part: To evaluate the efficacy and safety of ramucirumab plus nab-PTX.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase I part
primary endpoint: The frequency of Dose limiting toxicity(DLT)
Phase II part
primary endpoint: Overall response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ramucirumab: 8mg/kg(i.v.) administration at day 1,15,29
Nab-Paclitaxel: 180-260mg/m2 administration at day 1,22 (dose escalation: level1= 180mg/m2,level 2 = 220mg/m2, level 3 = 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Age over 20 years old and under 75 years old
2.Histological confirmed unresectable advanced or recurrent gastric cancer
3. Refractory to fluoropyrimidine and platinum containing chemotherapy. Within 4 months after last chemotherapy.
4. ECOG performance status 0-1
5. Cases with measurable lesion
6. No adverse event over Grade2(NCI-CTCAE, Ver 4.02) attributable to prior surgery or chemotherapy
7. Peripheral sensory neuropathy<=Grade1
8. No prior therapy with paclitaxel
9. Cases with adequately maintained organ functions and fullfilling the following conditions within 2 weeks before registration.
a)leukocyte count <= 12000/mm3
b)neutrophil count >= 2000/ mm3
c)hemoglobin level >= 9.0g/ dL
d)platelet count >= 100,000/mm3
e)AST and ALT <=100IU/L, or AST and ALT <=200IU/L with liver metastases
f)total bilirbin < 1.5mg/dL
g)ALP<=2.5xULN in each institution
h)serum creatinine <=1.5xULN in each institution or creatinine clearance=>50ml/min
i)PT-INR<1.5 or PT<1.5xULN in each institution
j)APTT<=1.5xULN in each institution
k)Urinary protein is<1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria more than 2+, then a 24-hour must demonstrate<1000 mg of protein in 24 hours.
10.Cases expected to survive for 90 days or more
11.Written informed consent

Key exclusion criteria 1. History of severe drug allergy or hypersensitivity
2. Active or uncontrolled clinically serious infection
3. Evidence of any other serious disease
4. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma
5. History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization.
6. Receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents.
7. Receiving chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted.
8. Significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to study entry.
9. History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
10. Symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
11. Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
12. Uncontrolled arterial hypertension >150/>90mmHg despite standard medical management
13. Serious or non healing wound or peptic ulcer or bone fracture within 28 days prior to randomization
14. Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohns disease, ulcerative colitis, or chronic diarrhea
15.Massive ascites, pleural effusion, or cardiac effusion
16.The patient is pregnant or breastfeeding
17. Judged inappropriate by the investigators

Target sample size 68

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachio Fushida
Organization Digestive Disease Support Organization (DDSO)
Division name Gastroenterologic surgery
Zip code
Address 35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL 076-265-2000
Email junkino0416@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jun Kinoshita
Organization Digestive Disease Support Organization (DDSO)
Division name Gastroenterologic surgery
Zip code
Address 35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL 076-265-2000
Homepage URL
Email junkino0416@gmail.com

Sponsor
Institute Digestive Disease Support Organization (DDSO)
Institute
Department

Funding Source
Organization Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 15 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
2015 Year 12 Month 28 Day
Date of IRB
2015 Year 10 Month 01 Day
Anticipated trial start date
2016 Year 01 Month 15 Day
Last follow-up date
2018 Year 06 Month 28 Day
Date of closure to data entry
2018 Year 06 Month 28 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 15 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023554

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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