We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00543075
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).

Condition or disease Intervention/treatment Phase
Normal Renal Function Mildly Impaired Renal Function Moderately Impaired Renal Function Drug: Genasense (oblimersen, G3139) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function
Study Start Date : May 2006
Primary Completion Date : November 2007
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Genasense (oblimersen, G3139)
    3 mg/kg/day by intravenous infusion for up to 48 hours
    Other Names:
    • Oblimersen
    • G3139

Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics of oblimersen (G3139) [ Time Frame: Up to 58 hours after start of Genasense infusion ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Weeks and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key inclusion criteria:

  • Age > 18 years
  • Adequate organ function as determined < 7 days prior to starting study medication (except for renal function, as specified per protocol)
  • Creatinine clearance > 80 mL/min based on the Cockcroft-Gault formula for subjects in Group 1; or 50 to less than or equal to 80 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 2; or 30 to 49 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 3

Key exclusion criteria:

  • Significant medical disease
  • Prior organ allograft
  • Coexisting condition that would require the subject to continue therapy during the treatment (infusion) phase of the study with a drug known to alter renal function
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543075


Locations
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Genta Incorporated
Investigators
Principal Investigator: Harry Alcorn, PharmD Davita Clinical Research
More Information

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00543075     History of Changes
Other Study ID Numbers: GPK104
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: June 2008

Keywords provided by Genta Incorporated:
Renal Function
Adult
Genasense
oblimersen
G3139
Genta
Pharmacokinetics

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Oblimersen
Antineoplastic Agents