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

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ClinicalTrials.gov Identifier: NCT00615446
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : April 30, 2010
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: SU011248; Gemcitabine Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors
Study Start Date : March 2005
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A 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
Other Name: Sutent, sunitinib, SU11248, Gemzar


Outcome Measures

Primary Outcome Measures :
  1. To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ]
  2. To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615446


Locations
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier: NCT00615446     History of Changes
Other Study ID Numbers: A6181041
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Pfizer:
solid tumor malignancy, SU011248, sunitinib, neoplasms

Additional relevant MeSH terms:
Gemcitabine
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors