UMIN-CTR Clinical Trial

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

Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Surgical Oncology, Osaka City University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Surgical Oncology, Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪市立大学医学部附属病院

Date of disclosure of the study information

2017

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

None

Registered date

2017

Year

12

Month

28

Day

Last modified on

2019

Year

06

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034961