NCT00254540

Brief Summary

To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2005

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

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

First Submitted

Initial submission to the registry

November 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 11, 2010

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

3.2 years

First QC Date

November 14, 2005

Results QC Date

January 15, 2010

Last Update Submit

February 17, 2010

Conditions

Carcinoma, Renal Cell

Keywords

Ph2, RCC, SU011248, SUNITINIB

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Objective Response

    Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

    Day 28 of Cycles 1-4

Secondary Outcomes (15)

  • Progression-Free Survival (PFS)

    Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.

  • Time To Tumor Progression (TTP)

    Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.

  • Duration of Response (DR)

    Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.

  • Time to Tumor Response (TTR)

    Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.

  • Overall Survival Time

    once year. Up to 3 years after the completion of subject registration.

  • +10 more secondary outcomes

Study Arms (1)

SU-011248 capsule

EXPERIMENTAL
Drug: SU011248 capsule

Interventions

SU011248 capsuleDRUG

50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

SU-011248 capsule

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven renal cell carcinoma with metastases with a component of clear cell histology

You may not qualify if:

  • Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pfizer Investigational Site

Akita, Akita, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Tsukuba, Ibaragi, Japan

Location

Pfizer Investigational Site

Osaka, Osaka, Japan

Location

Pfizer Investigational Site

Sayama, Osaka, Japan

Location

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Location

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Location

Pfizer Investigational Site

Tokushima, Tokushima, Japan

Location

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Yamagata, Yamagata, Japan

Location

Pfizer Investigational Site

Fukuoka, Japan

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellPrimary hyperoxaluria type 2

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

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 16, 2005

Study Start

December 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 23, 2010

Results First Posted

February 11, 2010

Record last verified: 2010-02

Locations

JP(11)