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A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)

NCT00800865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-11-03

Study results available
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Summary

A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of participants already receiving cytotoxic therapy. Additional blood and urine samples will be collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing, respectively.

Conditions

Interventions

OTHER

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).

OTHER

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).

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-10-31
Completion
2009-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800865 on ClinicalTrials.gov