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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00543205
Other study ID # GPK103
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received October 10, 2007
Last updated November 4, 2011
Start date August 2005
Est. completion date May 2007

Study information

Verified date March 2009
Source Genta Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Genasense® (G3139, oblimersen sodium)
Genasense 7 mg/kg/day for 5 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genta Incorporated

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of G3139 6-day period No
Secondary Safety 30 days post last dose of study medication Yes
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