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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00542893
First received: October 10, 2007
Last updated: March 11, 2012
Last verified: March 2012
History of Changes
  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)
Drug: Genasense followed by DTIC; then DTIC alone
Drug: DTIC alone; then Genasense followed by DTIC
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine
U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Study Start Date: April 2006
Study Completion Date: September 2007
Arms Assigned Interventions
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

  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

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00542893     History of Changes
Other Study ID Numbers: GPK105
Study First Received: October 10, 2007
Last Updated: March 11, 2012
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

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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013