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NCT00615446 Clinical Trial

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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00615446
Other study ID # A6181041
Secondary ID
Status Completed
Phase Phase 1
First received February 1, 2008
Last updated April 29, 2010
Start date March 2005
Est. completion date May 2009

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 gemcitabine in patients with advanced solid tumors

Recruitment information / eligibility
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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• SU011248; Gemcitabine
Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity

Locations
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

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 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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Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
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