A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00618124
First received: February 1, 2008
Last updated: April 29, 2010
Last verified: April 2010
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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
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 May 19, 2013