Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment

This study has been terminated.

(Terminated due to very slow enrollment)

Sponsor:

Information provided by (Responsible Party):

Genta Incorporated

ClinicalTrials.gov Identifier:

NCT00543205

First received: October 10, 2007

Last updated: November 4, 2011

Last verified: March 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	October 10, 2007
Last Updated Date	November 4, 2011
Start Date ^ICMJE	August 2005
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 25, 2009)	Pharmacokinetics of G3139 [ Time Frame: 6-day period ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00543205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 25, 2009)	Safety [ Time Frame: 30 days post last dose of study medication ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
Official Title ^ICMJE	A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function
Brief Summary	This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Advanced Melanoma and Normal or Impaired Hepatic Function
Intervention ^ICMJE	Drug: Genasense® (G3139, oblimersen sodium) Genasense 7 mg/kg/day for 5 days Other Names: G3139 Oblimersen Oblimersen sodium
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	6
Completion Date	May 2007
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically confirmed diagnosis of malignant melanoma Metastatic Stage IV disease, or Stage III disease that is not surgically resectable ECOG Performance status of 0,1,or 2 Adequate venous access Agreement to practice effective methods of birth control Hepatically impaired consistent with Child-Pugh classification Grade B Exclusion Criteria: Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites Prior organ allograft Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy Known hypersensitive to DTIC Prior treatment with Genasense
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00543205
Other Study ID Numbers ^ICMJE	GPK103
Has Data Monitoring Committee	No
Responsible Party	Genta Incorporated
Study Sponsor ^ICMJE	Genta Incorporated
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Genta Incorporated
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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