NCT00800865

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

A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Tumors

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-12-02
• Last updated: 2015-11-03
• Results posted: 2011-10-04