This is a Phase I, Randomized, Open-Label, Cross-Over, Single-Center, Pharmacokinetic Study With Direct Benefit to the Subject. Subject Will be Randomized to 1 of 2 Groups

This study is ongoing, but not recruiting participants.

Sponsored by:	Genta Incorporated
Information provided by:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT00542893

Purpose

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

Condition	Intervention	Phase
Advanced Melanoma	Drug: Genasense® (G3139, oblimersen sodium)	Phase I

MedlinePlus related topics: Melanoma

Drug Information available for: Dacarbazine Oblimersen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Randomized, Open-Label, Cross-Over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma

Further study details as provided by Genta Incorporated:

Study Start Date:	April 2006
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	GPK105
Study First Received:	October 10, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00542893
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

bcl-2
Bcl-2
CFR
DTIC
ECOG

EMEA
MedDRA
NCI CTC
SAE

Study placed in the following topic categories:

Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 15, 2009