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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Satraplatin in combination with Paclitaxel
Sponsored by
Agennix
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Advanced non-small cell lung cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sarah Cannon Research Institute

Outcomes

Primary Outcome Measures

To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel

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

Full Information

First Posted
December 22, 2005
Last Updated
April 27, 2012
Sponsor
Agennix
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1. Study Identification

Unique Protocol Identification Number
NCT00268970
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agennix

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Advanced non-small cell lung cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Satraplatin in combination with Paclitaxel
Intervention Description
Paclitaxel 200 mg/m2 IV over 3 hours on day 1. Satraplatin 60 mg/m2 administered by mouth once daily for 5 consecutive days (days 1-5). Satraplatin will be administered within 2 hours following paclitaxel infusion on day 1. Subsequent doses on days 2-5 will be taken at approximately 24 hour intervals.
Primary Outcome Measure Information:
Title
To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

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

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