Phase 1
Completed N=31
A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)
Source: ClinicalTrials.gov NCT00800865 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Level of Biomarkers — 24.6; NA; 34.3; 23.0 Percent pCDC2-positive cells
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Biomarkers |
24.6; NA; 34.3; 23.0; NA; 23.7 | — |
| PRIMARY Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy |
1.40; NA; 2.05; NA; NA; 1.03 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00800865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.