NL-OMON45398
Completed
Not Applicable
Phase 0 proof of concept study: a clinical pharmacokinetic microdosing trial with gemcitabine - N16GEM: Gemcitabine microdosing trial
Antoni van Leeuwenhoek Ziekenhuis0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- metastatic bladder cancer and malignant mesothelioma
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \> 18 years.
- •2\. Indication for treatment with gemcitabine.
- •3\. Histologically or cytologically confirmed diagnosis of:
- •a. Locally advanced or metastatic non\-small cell lung cancer.
- •b. Locally advanced or metastatic bladder cancer.
- •c. Malignant mesothelioma
- •4\. Able and willing to give written informed consent.
- •5\. WHO performance status of 0 or 1\.
- •6\. Able and willing to undergo blood sampling for PK analysis.
- •7\. All toxicities related to prior treatment should have resolved to CTCAE grade 1 or less.
Exclusion Criteria
- •1\. Known hypersensitivity to gemcitabine.
- •2\. Prior treatment with gemcitabine within 30 days of the first dose.
- •3\. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study.
- •4\. Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- •5\. Known positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HC Ab) or has a known positive test result for human immunodeficiency virus (HIV) or a history of HIV disease.
- •6\. Serious medical or psychiatric condition that, in the opinion of the Investigator, should preclude the patient from participating in the study.
Outcomes
Primary Outcomes
Not specified
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