Solid Tumors Clinical Trial
Official title:
A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors
Verified date | April 2010 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors
Status | Completed |
Enrollment | 44 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
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 gemcitabine or SU011248 - Hypertension that cannot be controlled by medications |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine | From screening until at least 28 days beyond discontinuation of study treatment | No | |
Secondary | To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered | From screening until at least 28 days beyond discontinuation of study treatment | No | |
Secondary | To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease | From screening until at least 28 days beyond discontinuation of study treatment | No |
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