Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer

NCT00137423 | Completed Phase 2 Results

• 1 other identifier: A6181061
• Study Type: interventional
• Target: 107
• Locations: 7 countries
• Sites: 10

Brief Summary

To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen

Conditions

Carcinoma, Renal Cell Metastasis

Outcome Measures

Primary Outcomes (1)

• Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects

  Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Secondary Outcomes (7)

• Duration of Tumor Response

  4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

• Time to Tumor Progression (TTP)

  4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

• Progression Free Survival (PFS)

  4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

• Overall Survival

  4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

• Summary of FACIT Fatigue Scale Overall Score

  Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.

Study Arms (1)

SU011248 (sunitinib)

EXPERIMENTAL

Single-arm study

Drug: SU011248 (sunitinib)

Interventions

SU011248 (sunitinib) DRUG

37.5 mg/day, oral, continuous daily dosing

SU011248 (sunitinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven renal cell carcinoma with metastases.
• Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
• Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated with IFN-á alone must have received IFN-á for at least 4 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1.
• Adequate organ function

You may not qualify if:

• Prior treatment with any systemic therapy other than 1 cytokine-based therapy.
• Previous treatment on a SU011248 (sunitinib) clinical trial.
• Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
• Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
• Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval \>450 msec for males or \>470 msec for females.
• Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy).
• Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
• Known human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Pfizer Investigational Site

Stanford, California, 94305, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89135, United States

Location

Pfizer Investigational Site

Villejuif, 94805, France

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

München, 81664, Germany

Location

Pfizer Investigational Site

Thessaloniki, 56429, Greece

Location

Pfizer Investigational Site

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Pfizer Investigational Site

Lund, SE-221 85, Sweden

Location

Pfizer Investigational Site

Stockholm, 171 76, Sweden

Location

Pfizer Investigational Site

Sankt Gallen, CH-9007, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 28410911 DERIVED

• 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.

  PMID: 27238653 DERIVED

• 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.

  PMID: 25577718 DERIVED

• Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, Fountzilas G, Peschel C, Flodgren P, Maneval EC, Chen I, Vogelzang NJ. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009 Sep 1;27(25):4068-75. doi: 10.1200/JCO.2008.20.5476. Epub 2009 Aug 3.

  PMID: 19652072 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic 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: August 26, 2005
• First Posted: August 29, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: May 1, 2008
• Last Updated: September 30, 2009
• Results First Posted: July 8, 2009

Record last verified: 2009-09

Locations

DE (2); GR (1); FR (1); SE (2); NL (1); CH (1); US (2)