UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031285 |
|---|---|
| Receipt number | R000035715 |
| Scientific Title | A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2025/12/24 10:03:50 |
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Basic information
Public title
A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Acronym
weekly Nab-Paclitaxel+Ramucirumab for unresectable gastric cancer
Scientific Title
A phase II study of weekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Scientific Title:Acronym
weekly Nab-Paclitaxel+Ramucirumab for unresectable gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of weekly nab-Paclitaxel plus Ramucirumab as 2nd line chemotherapy for unresectable gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Progression-free survival (PFS)
Key secondary outcomes
Overall survival (OS)
Response rate (RR)
Disease control rate (DCR)
Safety (Safety)
Relative dose intensity (RDI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nab-Paclitaxel fixed dose
Ramcirmab fixed dose
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. Histopathologically confirmed gastric cancer.
2. Patients resisted first line chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer.
3. Patients with advanced/recurrent gastric cancer which are resistant to first line chemotherapy within 28 days before registration.
4. No influence of prior therapy.
5. PS 0-2
6. Age >=20
7. Expected more than 3 months survival
8. Adequate organ functions (within 14 days before registration)
Leu: >=3,000 /mm3, <=12,000 /mm3
Neu: >= 1,500 /mm3
Plt: >= 100,000 /mm3
Hemoglobin: >= 9.0 g/dL
ALT: <=ULNx2.5
AST: <=ULNx2.5
T-bil: =<1.5mg/dl
Scr: >= 1.5 mg/dl
9. With written informed consent
Key exclusion criteria
1. Patients with serious drug allergy
2. Patients with history of receiving paclitaxel treatment
3. Patients with infectious disease and febrile condition (over 38 centigrade)
4. Patiens with any other serious disease.
5. Patients with history of gastrointestinal perforation and fistula
6. Patients with venous thrombosis and fresh bleeding from intestinal tract.
7. Patients with serious heart disease
8. Presence of active multiple primaries. (Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded.)
9. Patients with peripheral neuropathy(=>Grade2)
10. Patients wit psychological illness
11. Pregnant or nursing female
12. Patient with brain metastasis.
13. Patient with mental illness
14. Not appropriate for the study at the physician's assessment
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgeryy
Zip code
7558505
Address
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Michihisa |
| Middle name | |
| Last name | Iida |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
miida@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi 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
Yamaguchi University Hospital Clinical Research Center
Address
1-1-1 Minami-Kogushi, Ube City, Yamaguchi Prefecture
Tel
0836-22-2428
me223@yamaguchi-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000035715&t
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
50
Results
This open-label single-arm multicenter phase II trial enrolled 50 patients with unresectable or recurrent gastric or esophagogastric junction adenocarcinoma previously treated with fluoropyrimidine-based chemotherapy between March 2018 and August 2021. The median progression-free survival was 5.8 months (95% CI 4.6-7.0) and the median overall survival was 12.5 months (95% CI 10.6-14.5). The objective response rate among patients with measurable lesions was 26.7% including one complete response.
Results date posted
| 2025 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of patients was 69 years (range, 31-79), and 33 (66.0%) were aged >=65 years. Among them, 47 of 50 patients (94.0%) were classified as PS0 or PS1. In addition, 40 of the 50 patients had previously received platinum- and fluoropyrimidine-based combination therapy, while the remaining 10 patients had received fluoropyrimidine-based chemotherapy, mainly as adjuvant therapy. The main metastatic sites were lymph nodes (36.0%), ascites (32.0%), peritoneal dissemination (32.0%), and liver metastases (20.0%), and 31 patients (60.0%) had measurable disease
Participant flow
This multicenter, open-label, single-arm, prospective phase II clinical trial conducted at nine institutions in Japan between March 2018 and August 2021 enrolled 50 patients with unresectable or recurrent gastric or esophagogastric junction adenocarcinoma who had previously undergone treatment with fluoropyrimidine-based chemotherapy.
Adverse events
The disease control rate was 80.0%. Grade >=3 neutropenia and leukopenia occurred in 50.0% and 26.0% of patients, respectively, while febrile neutropenia occurred in 2.0%. The relative dose intensity was 86.5% for nab-paclitaxel and 92.8% for ramucirumab.
Outcome measures
The median overall survival was 12.5 (95% CI 10.6-14.5) months. Among patients with measurable lesions the objective response rate was 26.7% including one case of complete response.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035715
