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

NCT00618124 | Completed Phase 1

• 1 other identifier: A6181044
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Solid Tumors; Breast Cancer; Neoplasms

Keywords

solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1

Outcome Measures

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.

  From Screening until disease progression or discontinuation of the study

Secondary Outcomes (2)

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

  From Cycle 1, Day 1 until discontinuation of the study

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

  From screening until disease progression or discontinuation of the study

Study Arms (1)

A

EXPERIMENTAL

Drug: SU011248; Capecitabine

Interventions

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.

Also known as: Sutent, sunitinib, SU11248, Xeloda

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Prior treatment with either SU011248 or capecitabine.
• Hypertension that cannot be controlled by medications

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Albuqurque, New Mexico, 87131, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Sunitinib; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 18, 2008
• Study Start: May 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 3, 2010

Record last verified: 2010-04

Locations

US (3)