NCT01219751

Brief Summary

To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 17, 2011

Status Verified

September 1, 2010

Enrollment Period

3.3 years

First QC Date

October 12, 2010

Last Update Submit

June 16, 2011

Conditions

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Tumor response is to be measured every 6 weeks. RECIST v.1.1 will be used to definte target lesion and non-target lesion and classify the response category.

    up to 12 months

Secondary Outcomes (3)

  • Progression free survival

    up to 24 months

  • overall survival

    up to 36 months

  • Safety

    up to 24 months

Study Arms (1)

Sunitinib

EXPERIMENTAL

Sunitinib 50 mg D1-D28 every 6 weeks

Drug: Sunitinib

Interventions

SunitinibDRUG

Sunitinib 50 mg D1-D28 every 6 weeks

Also known as: Sutene
Sunitinib

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type
  • Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
  • Measurable disease according to RECIST criteria
  • ECOG performance status 1 or better
  • Age 18 years or older
  • Adequate cardiac function
  • Adequate bone marrow, hepatic, and renal function
  • Life expectancy of ≥ 3 months
  • Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

You may not qualify if:

  • Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type
  • Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
  • Hypertension that cannot be controlled by medications (blood pressure \> 150/90 mmHg despite optimal medical therapy)
  • Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).
  • Pregnancy or breast feeding.
  • Other severe acute or chronic medical or psychiatric condition
  • Prior treatment on sunitinib, sorafenib, or bevacizumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Lee JL, Ahn JH, Lim HY, Park SH, Lee SH, Kim TM, Lee DH, Cho YM, Song C, Hong JH, Kim CS, Ahn H. Multicenter phase II study of sunitinib in patients with non-clear cell renal cell carcinoma. Ann Oncol. 2012 Aug;23(8):2108-2114. doi: 10.1093/annonc/mdr586. Epub 2012 Jan 6.

    PMID: 22228449DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

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 Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jae-Lyun Lee, MD, PhD

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

June 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 17, 2011

Record last verified: 2010-09

Locations

KR(1)