A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genta Incorporated
• Treatments: Dacarbazine; Oblimersen

Criteria

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