Sunitinib Non Small Cell Lung Cancer Patients Over 70
This study is ongoing, but not recruiting participants.
Sponsor:
US Oncology Research
Collaborator:
Pfizer
Information provided by:
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00864721
First received: March 18, 2009
Last updated: June 6, 2011
Last verified: June 2011
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 18, 2009 |
| Last Updated Date | June 6, 2011 |
| Start Date ICMJE | February 2009 |
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
The primary objective of the study is to evaluate efficacy, based on disease control rate (CR, PR, and SD at 6-weeks). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00864721 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
overall response rates,progression-free survival;time to progression,1-year survival, determining the tolerability and safety profile of sunitinib malate in this group of patients. [ Time Frame: course of the trial ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Sunitinib Non Small Cell Lung Cancer Patients Over 70 |
| Official Title ICMJE | Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70 |
| Brief Summary | The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Non Small Cell Lung Cancer |
| Intervention ICMJE | Drug: Sutent
Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. |
| Study Arm (s) | Experimental: Sunitinib Malate
Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Intervention: Drug: Sutent |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 63 |
| Completion Date | Not Provided |
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 70 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00864721 |
| Other Study ID Numbers ICMJE | 06-135 |
| Has Data Monitoring Committee | No |
| Responsible Party | Regulatory Specialist, US Oncology Research, Inc. |
| Study Sponsor ICMJE | US Oncology Research |
| Collaborators ICMJE | Pfizer |
| Investigators ICMJE | Not Provided |
| Information Provided By | US Oncology Research |
| Verification Date | June 2011 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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