Satraplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	December 22, 2005
Last Updated Date	August 14, 2007
Start Date ^†	December 2005
Current Primary Outcome Measures ^† (submitted: December 22, 2005)	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 ^† (submitted: December 22, 2005)	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.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	40
Estimated Completion Date	September 2007
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Histologically confirmed advanced NSCLC Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry. Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. ECOG performance status of ≤ 2.
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.