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Completed

NCT Number: NCT00615446

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

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

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Key information

Conditions

Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SU011248; Gemcitabine

Drug

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 names: Sutent, sunitinib, SU11248, Gemzar

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 14, 2008
Registry last updated
Apr 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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