This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administered i.v. in treatment cycles of 28 days.
Administered i.v. in treatment cycles of 28 days.
Novo Nordisk Investigational Site
Lyon, France
Novo Nordisk Investigational Site
Marseille, France
Novo Nordisk Investigational Site
Saint-Herblain, France
Novo Nordisk Investigational Site
Villejuif, France
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
Time frame: after max. 6 treatment cycles
Pharmacokinetics
Time frame: Initially
IL-21 antibody formation
Time frame: For the duration of the trial
Progression free survival
Time frame: For the duration of the trial
Patient reported outcomes
Time frame: For the duration of the trial
Biomarker assessments CA-125
Time frame: For the duration of the trial
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Novo Nordisk Investigational Site
Essen, Germany
Novo Nordisk Investigational Site
Marburg, Germany
Novo Nordisk Investigational Site
Wiesbaden, Germany