Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Tumors
Both
Tumors
Trial Information
Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies
Inclusion Criteria:
- Histologically confirmed malignancy that is metastatic or unresectable and for which
standard curative or palliative chemotherapy measures do not exist or are no longer
effective
- Life expectancy of at least 3 months
- Measurable or evaluable disease
- ECOG performance status of <= 2
- Willingness and ability to give informed consent
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Other chemotherapy treatment less than 4 weeks prior to enrollment
- Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose and Safety
Outcome Time Frame:
3 weeks
Safety Issue:
Yes
Principal Investigator
George Wilding, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
CO 04904
NCT ID:
NCT00125411
Start Date:
March 2007
Completion Date:
February 2009
Related Keywords:
- Tumors
- satraplatin
- docetaxel
- cancer
- Phase I
- advanced solid tumors
Name | Location |
|---|---|
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
