NCT00800865

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 4, 2011

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

December 1, 2008

Results QC Date

January 12, 2011

Last Update Submit

October 9, 2015

Conditions

Tumors

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Biomarker Evaluation Group I

OTHER

Biomarker evaluation before and after dosing with cytotoxic agent(s)

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

Biomarker Evaluation Group II

OTHER

Biomarker evaluation before and after dosing with cytotoxic agent(s)

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

Interventions

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).

Biomarker Evaluation Group I

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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(1-K):11-21

    RESULT

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2008

First Posted

December 2, 2008

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 3, 2015

Results First Posted

October 4, 2011

Record last verified: 2015-10