A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics
Phase 1
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Tumors
Both
Tumors
Trial Information
A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics
Inclusion Criteria:
Participant has solid tumor that will be treated with one of the following treatments:
- Gemcitabine monotherapy
- Cisplatin monotherapy
- Carboplatin monotherapy
- Gemcitabine and cisplatin combination therapy
- Gemcitabine and erlotinib combination therapy
- Gemcitabine and carboplatin combination therapy
- Cisplatin and vinorelbine combination therapy
- Cisplatin and pemetrexed combination therapy
- Carboplatin and vinorelbine combination therapy
- Carboplatin and pemetrexed combination therapy
Exclusion Criteria:
- Participant has had recent cancer treatments including chemotherapy or radiation
- Participant has been in an investigational study within the last 30 days
- Participant has a history of drug or alcohol abuse
- Participant is Human Immunodeficiency Virus (HIV) positive or has a history of
Hepatitis B or C
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Level of Biomarkers
Outcome Description:
Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).
Outcome Time Frame:
Baseline, 24, 32, and 48 hours post dose
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Institutional Review Board
Study ID:
MK-0000-097
NCT ID:
NCT00800865
Start Date:
January 2009
Completion Date:
October 2009
Related Keywords:
- Tumors
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