advanced epithelial Ovarian Cancer stage IIB-IV MedDRA version: 9.1 Level: LLT Classification code 10033162 Term: Ovarian epithelial cancer stage II MedDRA version: 9.1 Level: LLT Classification code 10033163 Term: Ovarian epithelial cancer stage III MedDRA version: 9.1 Level: LLT Classification code 10033164 Term: Ovarian epithelial cancer stage IV
Conditions
Interventions
Product Name: rIL-21
Product Code: NN028
Pharmaceutical Form: Solution for injection
CAS Number: 716840-32-3
Current Sponsor code: NN028
Other descriptive name: rIL-21
Concentration unit: mg/ml milli
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) 2.Advanced epithelial OC (stage IIB-IV), histologically confirmed according to AJCC (3) 3.Persistent or progressive disease after or relapse within 1 year of completion of first line platinum-containing chemotherapy 4.At least 1 measurable lesion = 5 cm in the largest diameter according to RECIST criteria or assessable disease defined as: a one-dimensional measurable lesion, mass with margins not clearly defined, lesions with both diameters 0.5 cm or less on radiographic imaging, palpable lesions under 2 cm or malignant ascites respectively combined with a 2 x UNL (in the absence of cirrhosis) of CA-125 measured within 2 weeks prior to inclusion in the trial. 5.18 years of age or above 6.ECOG performance status = 2 7.Haematopoietic and renal: a.White blood cell (WBC) = 2.5 x 10^9/L b.Absolute neutrophil count (ANC) = 1.5 x 10^9/L c.Platelet count = 100 x 10^9/L d.Haemoglobin = 6.2 mmol/L e.Lymphocytes = 0.8 x 10^9/L f.No signs of haemolytic anaemia g.Serum-creatinine = 177 µmol/L 8.Hepatic a.Bilirubin = 1.2 x UNL b.ALAT and ASAT/SGOT = 2.5 x UNL (if liver metastasis then = 4 x UNL) c.LDH = 2 x UNL 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.More than one prior chemotherapy regimen 2.First-line chemotherapy within 1 month prior to enrolment 3.Radiotherapy less than 4 weeks prior to start of treatment for bone metastasis and less than 8 weeks for visceral metastasis 4.Previous mediastinal or left thoracic irradiation 5.Bulky disease defined as 1 or more lesions > 5 cm in the largest diameter according to RECIST criteria 6.Documented positive serologic testing for hepatitis B or C within a year prior to start of treatment 7.History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anaemia) 8.History of any other active malignancy (except basal cell carcinoma of the skin and cervical cancer in situ) within 5 years prior to enrolment 9.Left ventricular ejection fraction < 0.50, determined by Multigated Acquisition (MUGA) or echocardiography 10.Cardiac disease within the last 12 months defined as: a.Decompensate heart failure (New York Heart Association (NYHA) class III or IV b.Unstable angina pectoris c.Myocardial infarction 11.Signs of CNS metastasis: either known brain metastasis or symptoms of brain metastasis 12.Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness 13.Any significant systemic disease which according to the investigator could compromise the safety of the subject or interfere with the trial objectives 14.Concurrent treatment with systemic corticosteroids (topical or inhaled corticosteroid treatment is permitted) 15.Known or suspected allergy to trial product or related products 16.Previous participation (treatment) in this trial 17.Concurrent participation in any other trial with experimental therapy 18.Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures (Adequate contraception includes: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine a safe dose of rIL-21 in combination with PLD, and to assess the efficacy of this combination in terms of overall response rate (RR). ;Secondary Objective: •To evaluate the PK of PLD and rIL-21 in subjects treated with a combination of rIL-21 and PLD •To evaluate PDs and PGs in subjects treated with a combination of rIL-21 and PLD •To assess safety of the treatment in terms of toxicity assessed through clinical adverse events and CTCAE laboratory and non-laboratory toxicities. •To assess PFS •To assess HRQL •To assess if antibodies against rIL-21 are induced during treatment ;Primary end point(s): The primary endpoint for safety of treatment is observed toxicity assessed using the US National Cancer Institute CTCAE version 3. DLT will be recorded and MTD will be determined according to criteria described in section 5.3.3. All patients included at MTD will be used in the efficacy assessment. The primary endpoint for tumour response is overall RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination. Tumour evaluations will be done according to RECIST (1) and GCIG criteria (2). | — |
Countries
France, Germany
Outcome results
None listed