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TerminatedNCT00543205Updated Nov 6, 2011

Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment

A Phase 2/3 interventional study of Genasense® (G3139, oblimersen sodium) in Advanced Melanoma and Normal or Impaired and Hepatic Function, sponsored by Genta Incorporated. Terminated. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-06.

Sponsored by Genta Incorporated · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Terminated due to very slow enrollment
Phase
Phase 2/3
Study type
Interventional
Enrollment
6
Ages
18 Years and older
Sex
Female
01

Study summary

This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.

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Conditions studied

  • Advanced Melanoma and Normal or Impaired
  • Hepatic Function

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03

In context

Melanoma

3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's enrollment of 6 is below the median of 38 across 2,350 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Genta Incorporated is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed diagnosis of malignant melanoma
  • Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
  • ECOG Performance status of 0,1,or 2
  • Adequate venous access
  • Agreement to practice effective methods of birth control
  • Hepatically impaired consistent with Child-Pugh classification Grade B

Exclusion criteria

Exclusion Criteria:

  • Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites
  • Prior organ allograft
  • Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy
  • Known hypersensitive to DTIC
  • Prior treatment with Genasense
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Interventions

  • DrugGenasense® (G3139, oblimersen sodium)

    Genasense 7 mg/kg/day for 5 days

    Also known as: G3139, Oblimersen, Oblimersen sodium

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What researchers measure

Primary outcomes

  1. Pharmacokinetics of G3139

    Time frame: 6-day period

Secondary outcomes

  1. Safety

    Time frame: 30 days post last dose of study medication

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00543205
Lead sponsor
Genta Incorporated
Responsible party
Sponsor
First posted
Oct 12, 2007
Start date
Aug 2005
Primary completion
May 2007
Completion
May 2007
Last update
Nov 6, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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