Advanced Melanoma and Normal or Impaired, Hepatic Function
Conditions
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.
Interventions
Genasense 7 mg/kg/day for 5 days
Sponsors
Genta Incorporated
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of G3139 | 6-day period |
Secondary
| Measure | Time frame |
|---|---|
| Safety | 30 days post last dose of study medication |
Outcome results
None listed