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Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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

A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function

NCT00543205•Genta Incorporated

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

•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

Key Dates

Start Date

August 1, 2005

Primary Completion Date

May 1, 2007

Completion Date

May 1, 2007

Last Updated

November 7, 2011

Enrollment

ACTUAL participants

Conditions

Advanced Melanoma and Normal or ImpairedHepatic Function

Interventions

Genasense® (G3139, oblimersen sodium)

DRUG

Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function

NCT05283915

Hepatic Function Abnormal

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COMPLETEDPHASE1

Pharmacokinetics Study in Patients With Impaired Hepatic Function

NCT02586194

Patients With Impaired Hepatic Function

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COMPLETEDPHASE1

Evaluating Patients With Impaired Hepatic Function

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function

Pharmacokinetics Study in Patients With Impaired Hepatic Function

Evaluating Patients With Impaired Hepatic Function

Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function

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A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function