A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together

Breast Cancer Clinical Trial

Official title:

A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618124
• Other study ID #: A6181044
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2008
• Last updated: April 29, 2010
• Start date: May 2005
• Est. completion date: July 2008

Study information

• Verified date: April 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists

• Patient has good performance status (ECOG 0 or 1)

Exclusion Criteria:

• Prior treatment with either SU011248 or capecitabine.

• Hypertension that cannot be controlled by medications

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Neoplasms
• Solid Tumors

Intervention

Drug:
• SU011248; Capecitabine
Dose finding study using SU011248 daily by oral capsule in a continuous regimen or administered for 4 out of every 6 weeks (Schedule 4/2) or 2 out of every 3 weeks (Schedule 2/1), with capecitabine administered 2 out of every 3 weeks until progression or unacceptable toxicity.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albuqurque	New Mexico
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.		From Screening until disease progression or discontinuation of the study	No
Secondary	To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered		From Cycle 1, Day 1 until discontinuation of the study	No
Secondary	To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease		From screening until disease progression or discontinuation of the study	No

External Links

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