Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy

This study has been terminated.

(Sponsor decided to discontinue study drug development.)

Sponsor:

Information provided by (Responsible Party):

Agennix

ClinicalTrials.gov Identifier:

NCT00093132

First received: October 1, 2004

Last updated: August 9, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 1, 2004
Last Updated Date	August 9, 2012
Start Date ^ICMJE	August 2004
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 8, 2012)	Determination of MTD and recommended dose for phase II trials [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00093132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy
Official Title ^ICMJE	A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
Brief Summary	PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria. WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that 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. RATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Carcinoma, Non-small Cell Lung Lung Cancer
Intervention ^ICMJE	Drug: 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 Arm (s)	Experimental: Satraplatin Satraplatin Intervention: Drug: Satraplatin
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	Terminated
Enrollment ^ICMJE	20
Completion Date	February 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Locally advanced or medically inoperable NSCLC (stage II or III) ECOG performance status score 0-2 Adequate bone marrow, liver, and pulmonary functions Life expectancy > three months. Exclusion Criteria: Prior malignancy Serious concurrent uncontrolled medical disorder. Uncontrolled or significant cardiovascular disease History of mastectomy Pregnant or breast-feeding patients are not eligible Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy
Gender	Both
Ages	18 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	NCT00093132
Other Study ID Numbers ^ICMJE	SAT1-04-02
Has Data Monitoring Committee	Not Provided
Responsible Party	Agennix
Study Sponsor ^ICMJE	Agennix
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Agennix
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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