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Tracking Information | |
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First Received Date † | December 22, 2005 |
Last Updated Date | August 14, 2007 |
Start Date † | December 2005 |
Current Primary Outcome Measures † |
To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00268970 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | Satraplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer |
Official Title † | Phase 2 Trial of First-Line Therapy With Satraplatin and Paclitaxel in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer (NSCLC) |
Brief Summary | The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). |
Detailed Description | This trial is designed to study the efficacy and safety of a novel oral platinum analog, satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line of treatment (patients who have not received chemotherapy for disease that has metastasized) of patients with advanced NSCLC. WHAT IS SATRAPLATIN: Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Non-Randomized, Open Label |
Condition † | Non-Small Cell Lung Cancer |
Intervention † | Drug: Satraplatin in combination with Paclitaxel |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Active, not recruiting |
Enrollment † | 40 |
Estimated Completion Date | September 2007 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00268970 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | GPC Biotech |
Collaborators †† | |
Investigators † | |
Information Provided By | GPC Biotech |
Verification Date | August 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |