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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00800865
First received: December 1, 2008
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Tumors
Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Level of Biomarkers [ Time Frame: Baseline, 24, 32, and 48 hours post dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.


Enrollment: 36
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800865

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00800865     History of Changes
Other Study ID Numbers: 0000-097, 2008_593
Study First Received: December 1, 2008
Results First Received: January 12, 2011
Last Updated: October 16, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014