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Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00414765
First received: December 21, 2006
Last updated: February 9, 2013
Last verified: February 2013

December 21, 2006
February 9, 2013
January 2006
March 2010   (final data collection date for primary outcome measure)
Pharmacokinetics of Aldesleukin [ Time Frame: over 19 days (4 PK assessments (blood) ] [ Designated as safety issue: No ]
Pharmacokinetics of Aldesleukin
Complete list of historical versions of study NCT00414765 on ClinicalTrials.gov Archive Site
Not Provided
no secondary outcome measures
Not Provided
Not Provided
 
Aldesleukin in Patients With Metastatic Renal Cell Carcinoma and Metastatic Melanoma
Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma and Metastatic Melanoma With Immunologic Correlative Studies

This study will evaluate the pharmacokinetics of aldesleukin in patients with metastatic renal cell cancer and metastatic melanoma

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Renal Cell Carcinoma
  • Metastatic Melanoma
Drug: Aldesleukin
Other Names:
  • Proleukin,
  • PRL002
Experimental: Aldesleukin
Intervention: Drug: Aldesleukin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Not Provided
March 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Performance Status Eastern Cooperative Oncology Group: 0 or 1
  • Adequate organ function

Exclusion criteria:

  • Pregnancy or lactation
  • Prior treatment with aldesleukin
  • Organ transplant Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414765
CPRL002A2201
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP