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

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 Overview

• Status: Completed
• Conditions: Tumors
• Intervention / Treatment: Other: Biomarker sample collection before and after dosing with cytotoxic agent(s); Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Biomarker Evaluation Group I; Biomarker evaluation before and after dosing with cytotoxic agent(s)	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).
Other: Biomarker Evaluation Group II; Biomarker evaluation before and after dosing with cytotoxic agent(s)	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Sun A, Lam R, Harman A, Pavlick A, Herman G, Dauffenbach L, Kerfoot C, Huang P, Cheng J, Demuth T, Iannone R. Induction of CDC2 phosphylation in skin biopsies from patients with solid tumors undergoing DNA-damaging chemotherapy. Global J Med Res. 2014;14(1-K):11-21

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: December 1, 2008
• First Submitted That Met QC Criteria: December 1, 2008
• First Posted (Estimate): December 2, 2008

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: October 9, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 0000-097; 2008_593