Know Cancer

or
forgot password

A Pharmacokinetic Study of GenasenseĀ® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
Advanced Melanoma and Normal or Impaired, Hepatic Function

Thank you

Trial Information

A Pharmacokinetic Study of GenasenseĀ® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetics of G3139

Outcome Time Frame:

6-day period

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GPK103

NCT ID:

NCT00543205

Start Date:

August 2005

Completion Date:

May 2007

Related Keywords:

  • Advanced Melanoma and Normal or Impaired
  • Hepatic Function
  • Melanoma

Name

Location