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

Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800865
• Other study ID #: 0000-097
• Secondary ID: 2008_593
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2008
• Last updated: October 9, 2015
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tumors

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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(

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No