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A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Female
Advanced Melanoma

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Trial Information

A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma


Inclusion Criteria:



- Metastatic Stage IV disease, or Stage III disease that is not surgically resectable

- ECOG Performance Status of 0, 1, or 2

- Life expectancy of at least 12 weeks

- Adequate venous access

- Agreement to practice effective method of birth control

Exclusion Criteria:

- Less than 3 weeks of recovery from prior major surgery or other therapy, including
radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine
therapy

- Significant medical disease

- Known hypersensitivity to phosphorothioate-containing oligonucleotides

- Known hypersensitivity to DTIC

- Pregnancy/Lactation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

GPK105

NCT ID:

NCT00542893

Start Date:

April 2006

Completion Date:

September 2007

Related Keywords:

  • Advanced Melanoma
  • bcl-2
  • Bcl-2
  • CFR
  • DTIC
  • ECOG
  • EMEA
  • MedDRA
  • NCI CTC
  • SAE
  • Melanoma

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