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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004742
Receipt No. R000005647
Scientific Title Multi-Center Phase II Clinical Trial on Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma after Failure of Treatment with 1st-Line TKI Therapy
Date of disclosure of the study information 2010/12/22
Last modified on 2017/06/23

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Basic information
Public title Multi-Center Phase II Clinical Trial on Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma after Failure of Treatment with 1st-Line TKI Therapy
Acronym Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma after Failure of Treatment with 1st-Line TKI Therapy
Scientific Title Multi-Center Phase II Clinical Trial on Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma after Failure of Treatment with 1st-Line TKI Therapy
Scientific Title:Acronym Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma after Failure of Treatment with 1st-Line TKI Therapy
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate efficacy and safety of everolimus in patients with unresectable or metastatic renal cell carcinoma after failure of treatment with 1st-line TKI therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes PFS
Key secondary outcomes 1) Overall survival from the initiation of TKI treatment as 1st-line therapy
2) Overall survival from the initiation of everolimus treatment
3) ORR
4) TTF
5) Safety profile
6) HRQOL

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 Everolimus 10 mg will be administered once daily under fasting condition. The dosage will be adjusted according to the discontinuation, reduction or withdrawal criteria due to adverse events.
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
18 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 clear cell renal cell carcinoma
2) Patients who received a singe agent of TKI treatment (sorafenib, sunitinib, pazopanib, axitinib) as 1st-line therapy and who meet all of the following criteria
- Patients with cancer progression during or after TKI treatment and who received the last dose of TKI within 8 weeks before enrollment
Disease progression is evaluated based on overall response using RECIST v.1.0; patients with PD are eligible for enrollment and investigator's assessment is also acceptable
- Patients who did not receive cytokine or chemotherapy 1 year prior to TKI treatment
- Patients who did not receive cytokine or chemotherapy as concomitant medication
3) Patients who have at least one measurable foci on CT or MRI
4) 18 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 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichiro Ozono
Organization Hamamatsu University School of Medicine
Division name Department of Urology
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2306
Email oznsei@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Sugiyama
Organization Hamamatsu University School of Medicine
Division name Department of Urology
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2306
Homepage URL
Email taka0311@hama-med.ac.jp

Sponsor
Institute Japanese Afinitor Clinical Trial Group of RCC (J-ACTOR)
Institute
Department

Funding Source
Organization CSPOR
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 浜松医科大学(静岡県)
北海道大学(北海道)
札幌医科大学(北海道)
北海道がんセンター(北海道)
弘前大学(青森県)
秋田大学(秋田県)
岩手医科大学(岩手県)
筑波大学(茨城県)
自治医科大学(栃木県)
獨協医科大学(栃木県)
伊勢崎市民病院(群馬県)
埼玉医科大学国際医療センター(埼玉県)
防衛医科大学校(埼玉県)
千葉大学(千葉県)
千葉県がんセンター(千葉県)
帝京大学ちば医療センター(千葉県)
東京慈恵会医科大学附属柏病院(千葉県)
慶應義塾大学(東京都)
東京大学(東京都)
帝京大学(東京都)
日本医科大学(東京都)
東京女子医科大学(東京都)
東京女子医科大学東医療センター(東京都)
横浜市立大学(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
北里大学(神奈川県)
東海大学(神奈川県)
聖マリアンナ医科大学(神奈川県)
神奈川県立がんセンター(神奈川県)
信州大学(長野県)
藤田保健衛生大学(愛知県)
岐阜大学(岐阜県)
金沢大学(石川県)
京都大学(京都府)
大阪大学(大阪府)
近畿大学(大阪府)
大阪府立成人病センター(大阪府)
奈良県立医科大学(奈良県)
和歌山県立医科大学(和歌山県)
岡山大学(岡山県)
岡山医療センター(岡山県)
倉敷中央病院(岡山県)
広島大学(広島県)
広島市立広島市民病院(広島県)
山口大学(山口県)
徳島大学(徳島県)
香川大学(香川県)
高知大学(高知県)
九州大学(福岡県)
佐賀県医療センター好生館(佐賀県)
熊本大学(熊本県)
宮崎大学(宮崎県)
鹿児島大学(鹿児島県)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28334974
Number of participants that the trial has enrolled
Results
A total of 57  patients were enrolled. Patients were administered 10 mg of everolimus q.d. orally. The primary efficacy endpoint was progression-free survival achieved by administration of everolimus.
RESULTS:
The median progression-free survival of patients administered everolimus was 5.03 months (95% confidence interval: 3.70-6.20). The median overall survival was not reached. The objective response rate was 9.4% (95% confidence interval: 3.1-20.7). The progression-free survival in the group of <100% relative dose intensity was 6.70 months (95% confidence interval: 4.13-11.60), and that in the group of 100% relative dose intensity was 3.77 months (hazard ratio: 2.79, 95% confidence interval: 2.77-5.63). The commonly observed adverse events and laboratory abnormalities were stomatitis (49.1%), hypertriglyceridemia (26.4%), interstitial lung disease (26.4%), anemia (22.6%) and hypercholesterolemia (22.6%).
CONCLUSION:
The median progression-free survival was almost similar to that recorded in the RECORD-1 study, whereas prolongation of overall survival was observed in the present study compared with the RECORD-1 study. The treatment outcomes of first-line vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy and second-line everolimus treatment in Japanese patients were successfully established in the present study.
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 Completed
Date of protocol fixation
2010 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2015 Year 01 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 17 Day
Last modified on
2017 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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