NCT00542893

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

First QC Date

October 10, 2007

Last Update Submit

March 11, 2012

Conditions

Advanced Melanoma

Keywords

bcl-2CFRDTICECOGEMEAMedDRANCI CTCSAE

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Interventions

Genasense® (G3139, oblimersen sodium)DRUG
Group 1Group 2
Genasense followed by DTIC; then DTIC aloneDRUG

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

Group 2
DTIC alone; then Genasense followed by DTICDRUG

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

Group 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

oblimersenDacarbazine

Intervention Hierarchy (Ancestors)

TriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 12, 2007

Study Start

April 1, 2006

Study Completion

September 1, 2007

Last Updated

March 13, 2012

Record last verified: 2012-03