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

Advanced Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542893
• Other study ID #: GPK105
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2007
• Last updated: March 11, 2012
• Start date: April 2006
• Est. completion date: September 2007

Study information

• Verified date: March 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Melanoma

Intervention

Drug:
• Genasense® (G3139, oblimersen sodium)

• Genasense followed by DTIC; then DTIC alone
Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
• DTIC alone; then Genasense followed by DTIC
Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated