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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Breast Cancer, Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

From Screening until disease progression or discontinuation of the study

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181044

NCT ID:

NCT00618124

Start Date:

May 2005

Completion Date:

July 2008

Related Keywords:

  • Solid Tumors
  • Breast Cancer
  • Neoplasms
  • solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteBristol, Tennessee  37620