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 Profile

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

Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Mar 2017

At a glance

  • Drugs Denenicokin (Primary) ; Sunitinib
  • Indications Renal cell carcinoma
  • Focus Adverse reactions
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 01 Nov 2012 Planned number of patients changed from 9 to 135.
    • 29 Aug 2012 New source identified and integrated (DRKS00004053: German Clinical Trials Register).
    • 19 Jan 2009 Planned number of patients changed from 18 to 9, as reported by ClinicalTrials.gov.
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