Unique ID issued by UMIN | UMIN000020579 |
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Receipt number | 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 19:35:44 |
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
A phase I/II study of ramucirumab plus nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
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
A phase I/II study of ramucirumab plus nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
Japan |
gastric cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Phase I part
primary endpoint: The frequency of Dose limiting toxicity(DLT)
Phase II part
primary endpoint: Overall response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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)
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
68
1st name | |
Middle name | |
Last name | Sachio Fushida |
Digestive Disease Support Organization (DDSO)
Gastroenterologic surgery
35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
076-265-2000
junkino0416@gmail.com
1st name | |
Middle name | |
Last name | Jun Kinoshita |
Digestive Disease Support Organization (DDSO)
Gastroenterologic surgery
35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
076-265-2000
junkino0416@gmail.com
Digestive Disease Support Organization (DDSO)
Digestive Disease Support Organization (DDSO)
Other
NO
2016 | Year | 01 | Month | 15 | Day |
Unpublished
Terminated
2015 | Year | 12 | Month | 28 | Day |
2015 | Year | 10 | Month | 01 | Day |
2016 | Year | 01 | Month | 15 | Day |
2018 | Year | 06 | Month | 28 | Day |
2018 | Year | 06 | Month | 28 | Day |
2016 | Year | 01 | Month | 15 | Day |
2019 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023554
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