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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Tumors

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00800865

0000-097

2008_593

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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