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Satraplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer
Registration Number
NCT00268970
Lead Sponsor
Agennix
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel3 months
Secondary Outcome Measures
NameTimeMethod
To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel3 months

Trial Locations

Locations (1)

Sarah Cannon Research Institute

🇺🇸

Nashville, Tennessee, United States

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