Treatment Protocol for Patients Continuing From SU011248 Protocols - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Pfizer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00569725

Purpose

To provide access to SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol. Because this is a continuation protocol for different studies, the population will consist of patients with different solid advanced malignancies treated with a variety of therapies including single agent SU011248 and in combination with chemotherapy, and placebo (patients who did not qualify for cross-over within the previous trial due to declining health status).

Condition	Intervention
Advanced Cancer Solid Tumors	Drug: SU011248

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Treatment Protocol for Patients Continuing From SU011248 Protocols

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To provide access to Sutent® (sunitinib malate) for patients who have taken part in a research study using this drug. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

This study will also gather information about long-term treatment with sunitinib malate, including the safety and effectiveness as a treatment for cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator SU011248	Drug: SU011248 50 mg PO Daily

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have participated in a previous SU011248 protocol, and are judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician.
Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.

Exclusion:

Current treatment in another clinical research trial (other than SU011248)
Symptomatic or uncontrolled CNS metastases.
Symptomatic congestive heart failure.
Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569725

Contacts

Contact: Christopher Logothetis, MD

713-792-2830

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Christopher Logothetis, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Pfizer

Investigators

Principal Investigator:

Christopher Logothetis, MD

U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Christopher Logothetis, MD/Chair )
Study ID Numbers:	2006-0877
Study First Received:	December 5, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00569725
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancer
Solid Tumors
SU011248
Sunitinib

Study placed in the following topic categories:

Sunitinib

Additional relevant MeSH terms:

Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009