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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Indianapolis, Indiana, 46202 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumors, Breast Cancer, Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with either SU011248 or capecitabine.

- Hypertension that cannot be controlled by medications

NCT00618124
Pfizer
Completed
A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together

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A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together
A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Solid Tumors
  • Breast Cancer
  • Neoplasms
Drug: SU011248; Capecitabine
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 Name: Sutent, sunitinib, SU11248, Xeloda
Experimental: A
Intervention: Drug: SU011248; Capecitabine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
July 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00618124
A6181044
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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