Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
Phase 2
Terminated
- Conditions
- Advanced Melanoma and Normal or ImpairedHepatic Function
- Registration Number
- NCT00543205
- Lead Sponsor
- Genta Incorporated
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 6
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pharmacokinetics of G3139 6-day period
- Secondary Outcome Measures
Name Time Method Safety 30 days post last dose of study medication