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

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

Completed

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Key information

Conditions

Advanced Melanoma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genasense® (G3139, oblimersen sodium)

Drug

Genasense followed by DTIC; then DTIC alone

Drug

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

Drug

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

Sponsors and collaborators

Lead sponsor

Genta Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Study completion: 2007
First posted: Oct 12, 2007
Registry last updated: Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed