UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020579
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

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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 or person

Institute

Digestive Disease Support Organization (DDSO)

Institute

Department

Personal name



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

Value
https://center6.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