Treatment with Anakinra for patients with anaplastic thyroid cancer

Phase 1

• Conditions: Anaplastic Thyroid Carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003028-59-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

- newly diagnosed patients with a proven diagnosis (cytology or histology) of ATC, for whom surgery is not feasible.
- Patients with proven ATC (cytology or histology), presenting with metastasis not amendable for surgery.
- age = 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- unable to give informed consent
- pregnancy or breast feeding
- neutropenia (absolute neutrophil count (ANC)< 1.5 x10^9/l)
- patients with a known history of allergic reactions to compounds of similar chemical or biological composition to Anakinra.
- Any severe condition which could interfere with participation in this trial, including, but not limited to: severe renal dysfunction (creatinin clearance < 15 ml/min), severe cardiac failure, severe respiratory conditions etc.
- Active infection; However, after adequate treatment of infections, patients will be eligible for inclusion again.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified