CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Biomarker sample collection before and after dosing with cytotoxic agent(s) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00800865
NCT00800865Phase 1Completed
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A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics

Merck Sharp & Dohme LLC·interventional·Posted Dec 2, 2008·Updated Nov 3, 2015

In Brief

A Phase 1 clinical trial evaluating Biomarker sample collection before and after dosing with cytotoxic agent(s) for Tumors. Completed, enrolled 36 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumors
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2008
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.6 years ago

Interventions

Biomarker sample collection before and after dosing with cytotoxic agent(s)other

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)other

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).