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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00618124
First received: February 1, 2008
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Solid Tumors
Breast Cancer
Neoplasms
Drug: SU011248; Capecitabine
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 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine 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 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 ] [ Designated as safety issue: No ]

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

Enrollment: 77
Study Start Date: May 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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

  Eligibility

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

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
  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: NCT00618124

Locations
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, New Mexico
Pfizer Investigational Site
Albuqurque, New Mexico, United States, 87131
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier: NCT00618124     History of Changes
Other Study ID Numbers: A6181044
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, capecitabine, Phase 1

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014