Hepatic Function Clinical Trial
Official title:
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
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 |
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.
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 |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Genta Incorporated |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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