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A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumors

Intervention: SU011248; Gemcitabine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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

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

Primary outcome: To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine

Secondary outcome:

To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered

To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Boston, Massachusetts 02114, United States

Pfizer Investigational Site, Boston, Massachusetts 02115, United States

Pfizer Investigational Site, Boston, Massachusetts 02215, United States

Additional Information

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

Starting date: March 2005
Last updated: April 29, 2010

Page last updated: August 23, 2015

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