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A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00542893•Genta Incorporated

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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

Key Dates

Start Date

April 1, 2006

Completion Date

September 1, 2007

Last Updated

March 13, 2012

Conditions

Advanced Melanoma

Interventions

Genasense® (G3139, oblimersen sodium)

DRUG

Genasense followed by DTIC; then DTIC alone

DRUG

DTIC alone; then Genasense followed by DTIC

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

A Phase II Trial of LM103 in Advanced Melanoma

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis

HS-IT101 Injection in the Treatment of Advanced Melanoma