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A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

A Phase 1 Study Of SU011248 And Gemcitabine 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 gemcitabine or SU011248

- 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 on Schedule 4/2 or 2/1) when given in combination with gemcitabine

Outcome Time Frame:

From screening until at least 28 days beyond discontinuation of study treatment

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:

A6181041

NCT ID:

NCT00615446

Start Date:

March 2005

Completion Date:

May 2009

Related Keywords:

  • Solid Tumors
  • solid tumor malignancy, SU011248, sunitinib, neoplasms
  • Neoplasms

Name

Location
Pfizer Investigational Site North Adams, Massachusetts  01247