Proof of principle and pharmacological phase 0 study with improved solubility Pazopanib (PazSol001)

Recruiting

• Conditions: Advanced renal cell cancer; 10038364; Advanced renal cell carcinoma

• Registration Number: NL-OMON43192
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Locally advanced or metastatic cancer;
2. Age >= 18 years;
3. Able and willing to give written informed consent;
4. WHO performance status of 0, 1 or 2;
5. Able and willing to undergo blood sampling for PK analysis;
6. Minimal acceptable safety laboratory values
a. ANC of >= 1.5 x 109 /L
b. Platelet count of >= 100 x 109 /L
c. Hepatic function as defined by serum bilirubin <= 1.5 x ULN, ALAT and ASAT <= 2.5 x ULN
d. Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula).
7. Negative pregnancy test (urine/serum) for female patients with childbearing potential;
8. Able and willing to swallow oral medication;

Exclusion Criteria

1. Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;
2. Any treatment with inhibitors of CYP3A4 (e.g. boceprevir, claritromycine, erytromycine, indinavir, itraconazol, ketoconazol, ritonavir and voriconazol), inhibitors of Pgp (e.g. ciclosporine, kinidine and verapamil), inhibitors of BCRP (e.g. lapatinib), inductors of CYP3A4, Pgp or BCRP or stomach pH increasing drugs;
3. Patients who have had previous treatment with Votrient®, less than 1 week ago;
4. Woman who are pregnant or breast feeding;
5. Patients suffering from any known disease or dysfunction that might influence the dissolution and/or absorption of Pazopanib (e.g. dyspepsia, inflammatory bowel disease).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the concentration of Pazopanib in patient<br /><br>plasma.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The second study parameter will be the preliminary safety assessment of<br /><br>PazSol001.</p><br>