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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
Not Enrolling
Both
Tumors

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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 CenterMadison, Wisconsin  53792