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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tumors

Intervention / Treatment
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* Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)
* Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biomarker Evaluation Group I<br>Biomarker evaluation before and after dosing with cytotoxic agent(s) | Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)<br>* 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).<br>|
| Other: Biomarker Evaluation Group II<br>Biomarker evaluation before and after dosing with cytotoxic agent(s) | Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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