NCT00830895

Brief Summary

To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

January 27, 2009

Last Update Submit

November 6, 2022

Conditions

Renal Cell Carcinoma

Keywords

Renal cell carcinomaNon-clear cellRAD001Metastatic, non-clear cell, renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    It is the time from treatment initiation until disease progression.

    2 months, 4 months, 6 months

Secondary Outcomes (5)

  • Response rate

    2 months, 4 months, 6 months

  • Disease-control rate

    2 months, 4 months, 6 months

  • Overall survival

    2 months, 4 months, 6 months

  • Metabolic response rate by FDG-PET

    2 months, 4 months, 6 months

  • Safety

    monthly

Study Arms (1)

RAD001

EXPERIMENTAL

RAD001 10mg/day

Drug: RAD001

Interventions

RAD001DRUG

RAD001 10mg/day

RAD001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)
  • Subjects with metastatic legion
  • Subjects aged 18 years or older
  • Subjects whose ECOG performance status is 0 or 1
  • Subjects who have laboratory value below; Hematology
  • Neutrophil \>= 1.5 x 109/L
  • Platelet \>= 75 x 109/L
  • Hemoglobin \>= 9 g/dL Liver function tests
  • Total bilirubin ≤ 1.5 xULN
  • AST, ALT ≤ 2.5 xULN
  • Alkaline phosphatase ≤ 2.5 xULN Renal function tests
  • Creatinine clearance \>= 30 mL/min
  • Subjects who understand and provide a written informed consent

You may not qualify if:

  • Subjects who have been administered an mTOR inhibitor
  • Pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative
  • Subjects who participated in a clinical study using the study medication within 30 days before randomization
  • Subjects with clinically uncontrolled central nervous system (CNS) metastasis
  • Subjects with life expectancy of less than 3 months
  • Subjects with interstitial pulmonary disease
  • Subjects whose QTc interval is prolonged (QTc \> 450 msec for male or \> 470 msec for female)
  • Other serious diseases or medical conditions Heart disease unstable despite treatment History of myocardial infarction within six months before the study History of serious neurological or psychological disorder including dementia or seizure Active peptic ulcer which cannot be controlled by a drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Koh Y, Lim HY, Ahn JH, Lee JL, Rha SY, Kim YJ, Kim TM, Lee SH. Phase II trial of everolimus for the treatment of nonclear-cell renal cell carcinoma. Ann Oncol. 2013 Apr;24(4):1026-31. doi: 10.1093/annonc/mds582. Epub 2012 Nov 23.

    PMID: 23180114DERIVED

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasm Metastasis

Interventions

Everolimus

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2012

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

KR(1)