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OpenTrials
Completed

NCT Number: NCT00618124

A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together

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

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Key information

Conditions

Solid Tumors Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Indianapolis, Indiana, United States

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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 SU011248 or capecitabine.
  • Hypertension that cannot be controlled by medications

Treatment and study plan

SU011248; Capecitabine

Drug

Dose finding study using SU011248 daily by oral capsule in a continuous regimen or administered for 4 out of every 6 weeks (Schedule 4/2) or 2 out of every 3 weeks (Schedule 2/1), with capecitabine administered 2 out of every 3 weeks until progression or unacceptable toxicity.

Other names: Sutent, sunitinib, SU11248, Xeloda

Primary outcomes

  1. To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.

    Time frame: From Screening until disease progression or discontinuation of the study

Secondary outcomes

  1. To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered

    Time frame: From Cycle 1, Day 1 until discontinuation of the study

  2. To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease

    Time frame: From screening until disease progression or discontinuation of the study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 18, 2008
Registry last updated
May 3, 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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