An open-label cross-over proof of concept study to investigate the intratumoral pharmacokinetics of CriPec® docetaxel versus Taxotere® (the CRITAX study)

Completed

Conditions: cancer malignancy
10027656

Registration Number: NL-OMON47152

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Age * 18;Patients with advanced, unresectable and/or refractory solid tumors with no standard therapy options who could benefit from treatment with taxane containing chemotherapy;Signed informed consent;WHO Performance Status 0 or 1;Adequate organ function as defined by:;* Total bilirubine > 1.5 x ULN if no liver metastases (> 2 x ULN in patients with liver metastases). Except in case of documented Gilbert*s disease ;* AST or ALT > 2.5 x ULN if no liver metastases (> 5x ULN in patients with liver metastases);* Creatinine > 1.5 x ULN;Estimated life expectancy of at least 12 weeks;Willing to undergo repeated tumor and skin biopsies

Exclusion Criteria

Pregnant or lactating patients;Less than 4 weeks (prior to Cycle 1 Day 1) treatment with another Investigational Product or participation in another investigational interventional study.;Less than 4 weeks since the last anti-cancer therapy prior to Cycle 1 Day 1;Toxicities incurred as a result of previous anti-cancer therapy that have not resolved to * grade 2 except skin toxicity, this should be grade 0 at the base line;Known hypersensitivity to any of the Investigational Product*s excipients or taxanes;Symptomatic brain metastasis ;Patients unable to undergo study procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To show a 25% difference in concentration of docetaxel in tumor tissue after<br /><br>administration of CriPec® docetaxel compared to Taxotere®.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Systemic pharmacokinetics and adverse events:<br /><br>1. Plasma levels of total and free docetaxel up to 24 hours after dosing and at<br /><br>the time of biopsy; Cmax, Tmax, AUClast, AUCinf, Thalf, Cl, Vss in relation to<br /><br>body weight (kg) where applicable.<br /><br>3. The incidence of Grade 3 or 4 adverse events during cycle 1 and 2 according<br /><br>to CTCAE, version 4.03.<br /><br><br /><br>Docetaxel PK and pathological changes in the skin after treatmet with CriPec®<br /><br>docetaxel and Taxotere®.<br /><br><br /><br></p><br>