Clinical trial · Interventional
A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)
A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics
NCT00800865CI-TRIAL-00019678completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker sample collection before and after dosing with cytotoxic agent(s) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Biomarker Evaluation Group I
- description
- Biomarker evaluation before and after dosing with cytotoxic agent(s)
- interventionNames
- Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)
- type
- OTHER
- label
- Biomarker Evaluation Group II
- description
- Biomarker evaluation before and after dosing with cytotoxic agent(s)
- interventionNames
- Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)
Primary outcomes (2)
- measure
- Level of Biomarkers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSun 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