Clinical trial NCT00054886: Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
Official title: Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-02-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.


Eligibility criteria: Inclusion Criteria:

* Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
* The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
* Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function

Exclusion Criteria:

* Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
* Prior surgical resection of or irradiation to the only site of measurable disease;
* Ongoing severe hematuria;
* Other active second malignancy;
* Cardiovascular diseases or conditions within the last 12 months;
* Known brain metastases;
* Known HIV-positive or AIDS-related illness;
* Pregnant or breast-feeding women;
* Current participation in other clinical trials;
* Other severe acute or chronic medical conditions.

Primary outcomes:
measure: The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Secondary outcomes:
measure: The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Monterey Park
country: United States
facility: Pfizer Investigational Site
state: California
city: Northridge
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
citation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
citation: Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.