Cancer, Ovarian Cancer
Conditions
Brief summary
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.
Interventions
Administered i.v. in treatment cycles of 28 days.
DRUGcaelyx (pegylated liposomal doxorubicin)
Administered i.v. in treatment cycles of 28 days.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced epithelial Ovarian Cancer (stage IIB-IV) * Persistent or progressive disease after or relapse within one year of completion of first line therapy * Measurable or assessable disease * Eastern Cooperative Oncology Group status less than or equal to 2
Exclusion criteria
* History of any other active malignancy * Signs of CNS metastasis * More than one prior chemotherapy regimen * Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks * First line chemotherapy completed at least 1 month prior to start of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination. | after max. 6 treatment cycles |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Initially |
| IL-21 antibody formation | For the duration of the trial |
| Progression free survival | For the duration of the trial |
| Patient reported outcomes | For the duration of the trial |
| Biomarker assessments CA-125 | For the duration of the trial |
Countries
France, Germany
Outcome results
None listed