An open label, dose escalation safety and tolerability trial of the combination of s.c. recombinant human IL-21 (rIL-21) and sunitinib (phase 1) followed by an open label stratified randomized 2-arm trial of rIL-21 plus sunitinib versus sunitinib alone (phase 2a) in subjects with stage IV renal cell carcinoma. Trial Phase: 1/2a

• Conditions: Renal cell carcinoma stage IV; MedDRA version: 8.1Level: LLTClassification code 10038414

• Registration Number: EUCTR2006-005751-16-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

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.Histologically verified and surgically incurable stage IV RCC of clear cell type. (clear cell type only required for phase 2a)
3.18 years of age or above
4.ECOG performance status of 0 or 1. Please refer to Appendix F.
5.Life expectancy of at least 3 months
6.0-2 risk factors according to Motzer criteria (favourable or intermediate risk) (1). Please be referred to Appendix D.
7.Prior resection of the primary tumour required
8.Full recovery from surgery for stage IV disease
9.Remaining measurable disease (according to RECIST) required for phase 2a only.
Haematopoietic parameters:
10.White blood cell (WBC) higher/equal than 2.5 x 10 superscript 9/L
11.Absolute neutrophil count (ANC) higher/equal than 1.5 x 10 superscript 9/L
12.Platelet count higher/equal than 100 x 10 superscript 9/L
13.Haemoglobin higher/equal than 6.2 mmol/L
14.No signs of haemolytic anaemia
15.Serum creatinine less/equal than 177 µmol/L
Hepatic parameters:
16.Bilirubin less/equal than 1.25 x upper limit of normal (ULN)
17.AST/SGOT less/equal than 2.5 x ULN
18.LDH less/equal than 2x upper limit of normal
19.Negative serologic testing for Hepatitis B and C
20. ALT = 2.5 x ULN

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

1.Previous systemic treatment for stage IV disease
2.Rare histological subtypes of RCC (true papillary, collecting duct, sarcomatoid features) applies for phase 2a only
3.History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anaemia)
4.History of any other active malignancy (except basal cell carcinoma of the skin and cervical cancer in situ) within five years prior to enrolment
5.Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
6.Any significant systemic disease which according to the Investigator could compromise the safety of the subject or interfere with the trial objectives
7.Concurrent treatment with systemic corticosteroids (topical or inhaled corticosteroid treatment is permitted)
8.Known or suspected allergy to trial products or related products
9.Previous participation in this trial (re-screening is allowed when agreed with the Local Trial Manager or the International Trial Manager)
10.Pregnant, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any). In Germany adequate contraception is: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence, or vasectomised partner. No specific requirements in the Netherlands.
11.The receipt of any investigational drug within 3 months prior to start on this trial (day 1)
12.The receipt of concomitant anti-coagulation therapy Low Molecular Weight (LMW) heparins allowed).
13.Cerebrovascular accident or transient ischemic attack within the last 12 months
14.Deep venous thrombosis or pulmonary embolism within the last 12 months
Cardiac events within the last 12 months, such as:
15.Myocardial infarction
16.Severe/unstable angina
17.Coronary/peripheral artery bypass graft
18.Symptomatic congestive heart failure (CHF)
Radiotherepy:
19. Radiotherapy within the last 4 weeks prior to start of treatment

Study & Design

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