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

Phase 1

Completed

• Conditions: Tumors
• Interventions: Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)

• Registration Number: NCT00800865
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Study Start: 2009-01
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2011-01-12
• Results First Submitted QC: 2011-08-23
• Results First Posted: 2011-10-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biomarker Evaluation Group I	Biomarker sample collection before and after dosing with cytotoxic agent(s)	Biomarker evaluation before and after dosing with cytotoxic agent(s)
Biomarker Evaluation Group II	Biomarker sample collection before and after dosing with cytotoxic agent(s)	Biomarker evaluation before and after dosing with cytotoxic agent(s)

Primary Outcome Measures

Name	Time	Method
Level of Biomarkers	Baseline, 24, 32, and 48 hours post dose	Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy	24, 32, and 48 hours post dose	Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.