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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tumors Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

Level of Biomarkers

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Dec 2, 2008
Registry last updated: Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed