Study Stopped
Sponsor decided to discontinue study drug development.
Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy
A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2004
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 1, 2004
CompletedFirst Posted
Study publicly available on registry
October 4, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedAugust 17, 2012
August 1, 2012
4.4 years
October 1, 2004
August 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of MTD and recommended dose for phase II trials
30 days
Study Arms (1)
Satraplatin
EXPERIMENTALSatraplatin
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agennixlead
Study Sites (1)
Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2004
First Posted
October 4, 2004
Study Start
August 1, 2004
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
August 17, 2012
Record last verified: 2012-08