Phase 0 proof of concept study: a clinical pharmacokinetic microdosing trial with gemcitabine

Completed

• Conditions: metastatic bladder cancer and malignant mesothelioma; Metastatic non-small cell lung cancer; 10027655

• Registration Number: NL-OMON45398
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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.
8. Willing and able to comply with study restrictions and to remain at the study center for the required duration.
9. Adequate organ system function.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To study the pharmacokinetics after administration of a microdose and the<br /><br>pharmacokinetics after administration of a therapeutic dose.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To analyse patient plasma with liquid chromatography-mass spectrometry<br /><br>(LC-MS/MS)</p><br>