A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)
NCT ID: NCT00800865
Last Updated: 2015-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2009-01-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Biomarker Evaluation Group I
Biomarker evaluation before and after dosing with cytotoxic agent(s)
Biomarker sample collection before and after dosing with cytotoxic agent(s)
Participants will have blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s).
Biomarker Evaluation Group II
Biomarker evaluation before and after dosing with cytotoxic agent(s)
Biomarker sample collection before and after dosing with cytotoxic agent(s)
A second group of participants will have blood and urine samples collected at Visit 1 (there is no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
Interventions
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Biomarker sample collection before and after dosing with cytotoxic agent(s)
Participants will have blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s).
Biomarker sample collection before and after dosing with cytotoxic agent(s)
A second group of participants will have blood and urine samples collected at Visit 1 (there is no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Sun A, Lam R, Harman A, Pavlick A, Herman G, Dauffenbach L, Kerfoot C, Huang P, Cheng J, Demuth T, Iannone R. Induction of CDC2 phosphylation in skin biopsies from patients with solid tumors undergoing DNA-damaging chemotherapy. Global J Med Res. 2014;14(1-K):11-21
Other Identifiers
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2008_593
Identifier Type: -
Identifier Source: secondary_id
0000-097
Identifier Type: -
Identifier Source: org_study_id
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