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Completed

NCT Number: NCT00617253

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

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.

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Key information

Conditions

Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Frankfurt, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant interleukin-21

Drug

3 mcg/kg, s.c. injection

Other names: NN028, rIL-21

Sunitinib

Drug

Hard gelatine capsules, 12.5 mg

Other names: Sutent®

Primary outcomes

  1. Toxicity according to CTCAE version 3.0

    Time frame: For the duration of the trial

Secondary outcomes

  1. Pharmacokinetics

    Time frame: For the duration of the trial

  2. rIL-21 antibodies

    Time frame: For the duration of the trial

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 15, 2008
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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