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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 1, 2008
Last updated: April 29, 2010
Last verified: April 2010
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 Intervention Phase
Solid Tumors
Drug: SU011248; Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615446

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
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 
Study First Received: February 1, 2008
Last Updated: April 29, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016