Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004053

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004053
  •   2012/07/31
  •   2008/02/04
  •   no
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Secondary IDs

  •   2006-005751-16 
  •   NCT00617253  (ClinicalTrials.gov)
  •   NN028-1642  (Novo Nordisk)
  •   2006-005751-16 
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Health Condition or Problem studied

  •   Cancer
  •   Renal Cell Carcinoma
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  •   Drug: recombinant interleukin-21
  •   Drug: sunitinib
  •   Drug: recombinant interleukin-21
  •   Drug: recombinant interleukin-21
  •   Drug: recombinant interleukin-21
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
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Primary Outcome

- Toxicity according to CTCAE version 3.0; time frame: For the duration of the trial

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Secondary Outcome

- Pharmacokinetics; time frame: For the duration of the trial
- rIL-21 antibodies; time frame: For the duration of the trial

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Countries of Recruitment

  •   Germany
  •   Netherlands
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Locations of Recruitment

  •  
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Recruitment

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  •   2007/07/31
  •   9
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Novo Nordisk A/S
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    • Novo Nordisk A/S
    • Paul Kristjansen, MD, PhD, DMSc 
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    • Novo Nordisk A/S
    • Paul Kristjansen, MD, PhD, DMSc 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2008/06/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.