Clinical Trials Logo
  1. Home
  2. Cancer
  3. NCT00617253
  4. Details
NCT00617253 Clinical Trial

Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients

Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00617253
Other study ID # NN028-1642
Secondary ID 2006-005751-16
Status Completed
Phase Phase 2
First received February 4, 2008
Last updated February 28, 2017
Start date July 12, 2007
Est. completion date June 30, 2008

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib.

The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date June 30, 2008
Est. primary completion date June 30, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically verified and surgically incurable stage IV Renal Cell Carcinoma

- ECOG performance status of 0 or 1 (i.e. good performance status)

- Life expectancy of at least 3 months

Exclusion Criteria:

- Prior systemic therapy for metastatic disease

- Radiotherapy within the last 4 weeks prior to start of treatment

- Receipt of any investigational drug within 3 months of starting treatment

- History of any other active malignancy within five years prior to enrolment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant interleukin-21
3 mcg/kg, s.c. injection
• sunitinib
Hard gelatine capsules, 12.5 mg
• recombinant interleukin-21
10 mcg/kg, s.c. injection
• recombinant interleukin-21
30 mcg/kg, s.c. injection
• recombinant interleukin-21
100 mcg/kg, s.c. injection

Locations
Country Name City State
Germany Novo Nordisk Investigational Site Frankfurt
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hannover
Netherlands Novo Nordisk Investigational Site Amsterdam
Netherlands Novo Nordisk Investigational Site Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Toxicity according to CTCAE version 3.0 For the duration of the trial
Secondary Pharmacokinetics For the duration of the trial
Secondary rIL-21 antibodies For the duration of the trial
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients

External Links