NCT03712423

PET Study With [89Zr]-Df-CriPec® Docetaxel

A Clinical Phase I, Open-label, PET Study With [89Zr]-Df-CriPec® Docetaxel in Patients With Solid Tumours to Assess Biodistribution and Tumour Accumulation of [89Zr]-Df-CriPec® Docetaxel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A clinical phase I, open-label PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel.

Detailed description

After patient inclusion an fludeoxyglucose-18 (\[18F\]-FDG) PET scan will be performed to delineate viable tumour lesions. On day 1, patients will receive a low dose of \[89Zr\]-Df-CriPec® docetaxel (corresponding to approximately 0.1-1 mg docetaxel) followed by maximally 3 \[89Zr\] PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 h - 9 days after administration) to evaluate biodistribution and tumour uptake. Two weeks later, the patients will receive unlabelled CriPec® docetaxel up to the Recommended Phase II Dose (RP2D) given every 3 weeks (Q3W) that will be determined in the phase I NAPOLY trial (CT-CL01), immediately followed by a second low dose of \[89Zr\]-Df-CriPec® docetaxel and maximally 3 \[89Zr\]PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 hrs - 9 days after administration) to evaluate biodistribution and tumour uptake with therapeutic dosage.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Cripec Docetaxel	89 Zirconium Cripec Docetaxel PET

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-03-25
• Completion: 2020-05-08
• First posted: 2018-10-19
• Last updated: 2020-10-08

Locations

1 site across 1 country: Netherlands