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

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ClinicalTrials.gov Identifier: NCT00542893
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated

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

Condition or disease Intervention/treatment Phase
Advanced Melanoma Drug: Genasense® (G3139, oblimersen sodium) Drug: Genasense followed by DTIC; then DTIC alone Drug: DTIC alone; then Genasense followed by DTIC Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma
Study Start Date : April 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine

Arm Intervention/treatment
Experimental: Group 1
Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
Drug: Genasense® (G3139, oblimersen sodium)
Drug: 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

Experimental: Group 2
Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
Drug: Genasense® (G3139, oblimersen sodium)
Drug: 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





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00542893     History of Changes
Other Study ID Numbers: GPK105
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Genta Incorporated:
bcl-2
CFR
DTIC
ECOG
EMEA
MedDRA
NCI CTC
SAE

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Oblimersen
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents