A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

Neoplasms Clinical Trial

Official title:

A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443534
• Other study ID #: A6181078
• Status: Completed
• Phase: N/A
• First received: March 2, 2007
• Last updated: April 2, 2013
• Start date: May 2006
• Est. completion date: December 2011

Study information

• Verified date: April 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.

Exclusion Criteria:

• Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• SU011248
Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
France	Pfizer Investigational Site	Lyon Cedex 08
France	Pfizer Investigational Site	Marseille Cedex 20
France	Pfizer Investigational Site	Villejuif
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Grosshansdorf
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Wiesbaden
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Cremona
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Orbassano (TO)
Italy	Pfizer Investigational Site	Rozzano (MI)
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Cordoba
Spain	Pfizer Investigational Site	Elche	Alicante
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bedford	Texas
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Clinton	North Carolina
United States	Pfizer Investigational Site	Creve Coeur	Missouri
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Goldsboro	North Carolina
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Hackensack	New Jersey
United States	Pfizer Investigational Site	Harvey	Illinois
United States	Pfizer Investigational Site	Harvey	Illinois
United States	Pfizer Investigational Site	Hershey	Pennsylvania
United States	Pfizer Investigational Site	Hickory	North Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Littleton	Colorado
United States	Pfizer Investigational Site	Maywood	Illinois
United States	Pfizer Investigational Site	Munster	Indiana
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Spartanburg	South Carolina
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Peters	Missouri
United States	Pfizer Investigational Site	Tinley Park	Illinois
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Wilson	North Carolina
United States	Pfizer Investigational Site	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival (OS)	Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).	Baseline, every 2 months until death or up to 2 years after the last dose of study treatment	No
Other	Progression-Free Survival (PFS)	Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").	Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication	No
Other	Time to Tumor Progression (TTP)	Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).	Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication	No
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Baseline up to Day 28 after last dose of study treatment	Yes

External Links

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