Treatment Protocol for Patients Continuing From SU011248 Protocols

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00569725
First received: December 5, 2007
Last updated: October 5, 2012
Last verified: October 2012
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Treatment Protocol for Patients Continuing From SU011248 Protocols

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To provide access to Sutent® (sunitinib malate) for patients having taken part in a research study using Sutent® while gathering information about long-term treatment safety and effectiveness. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: October 2007
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SU011248
SU011248 50 mg by mouth daily.
Drug: SU011248
50 mg by mouth daily
Other Name: Sunitinib

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.

Exclusion Criteria:

  1. Current treatment in another clinical research trial (other than SU011248)
  2. Symptomatic or uncontrolled CNS metastases.
  3. Symptomatic congestive heart failure.
  4. 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
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: NCT00569725

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
Principal Investigator: Amado Zurita, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00569725     History of Changes
Other Study ID Numbers: 2006-0877
Study First Received: December 5, 2007
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Solid Tumors
SU011248
Sunitinib

Additional relevant MeSH terms:
Neoplasms
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014