UMIN-CTR Clinical Trial

Public title

Efficacy and Safety of Everolimus in Patients with Non-Clear Cell Renal Cell Carcinoma

Acronym

Efficacy and Safety of Everolimus in Patients with Non-Clear Cell Renal Cell Carcinoma

Scientific Title

Efficacy and Safety of Everolimus in Patients with Non-Clear Cell Renal Cell Carcinoma

Scientific Title:Acronym

Efficacy and Safety of Everolimus in Patients with Non-Clear Cell Renal Cell Carcinoma

Region

Japan

Condition

Non-clear cell renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objective of this study is to evaluate efficacy and safety of everolimus in patients with unresectable or metastatic non-clear cell renal cell carcinoma for the patient who is not treating his whole body that excludes the cytokine therapy .
In addition , the influence that everolimus exerts on immunity is matched and examined.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progresstion Free Survival

Key secondary outcomes

Overall Survival , Objective Response Rate , Clinical Benefit Rate , immunity , Safety , QOL

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) Patients with unresectable or metastatic renal cell carcinoma who have confirmed histological or cytological diagnosis of non-clear cell renal cell carcinoma
2) Patients who received a
Patients with no previous history of chemotherapy, or molecularly targeted drug therapy excluded cytokine therapy
3) Patients who have at least one measurable foci on CT or MRI
4) 20 years old or older
5) ECOG PS 0-1
6) No interstitial pneumonia in the lungs observed on chest CT
7) Patients with sufficient hematopoietic function who meet the following all criteria
- Neutrophil >= 1,500/mm3
- Platelet >= 10 times 104/mm3
- Hemoglobin > 9.0 g/dL
8) Patients with sufficient hepatic functions who meet the following all criteria
- Total-bilirubin <= 1.5 times ULN
- AST and ALT <= 2.5 times ULN (patients with hepatic metastasis <= 5.0 times ULN)
9) Patients with sufficient renal function who meet the following criterion
Serum creatinine <= 1.5 times ULN
10) Patients whose fasting blood glucose <= 1.5 times ULN and blood glucose level is under control
11) Patients who meet the following all criteria
- Total-cholesterol <= 400 mg/dL
- Triglycerides <= 5.0 times ULN
12) More than 3 months of life expectancy
13) Patients (or legal representative in case of minority) who gave informed consent for participation to the study after they received explanation of the briefing document

Key exclusion criteria

1) Patients with history of hypersensitivity against everolimus or sirolimus derivative
2) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby
3) Patients who are on long-term treatment with corticosteroid or immunosuppressant
4) Patients treated for another primary malignancy within 3 years of enrollment
5) Patients judged ineligible to participate in the study by the investigator

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Hideyasu Matsuyama

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Urology

Zip code

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Shigeru Sakano

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Urology

Zip code

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan

TEL

0836222275

Homepage URL

Email

Institute

Yamaguchi University Graduate School of Medicine , Department of Urology

Institute

Department

Personal name

Organization

Yamaguchi University Graduate School of Medicine , Department of Urology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

10

Month

01

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

2011

Year

09

Month

28

Day

Date of IRB

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

not started

Registered date

2011

Year

08

Month

29

Day

Last modified on

2011

Year

08

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007394