Condition category
Cancer
Date applied
06/11/2002
Date assigned
06/11/2002
Last edited
07/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stan Frankel

ORCID ID

Contact details

Genta Incorporated
2 Connell Drive
Berkeley Heights
NJ 07922
United States of America
+1 888 322 2264
clinicaltrials@genta.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00016263

Protocol/serial number

GM301

Study information

Scientific title

Acronym

Study hypothesis

To compare the effectiveness of dacarbazine with or without oblimersen (G3139) in treating patients who have advanced malignant melanoma.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malignant melanoma stages III and IV

Intervention

Patients will be randomly assigned to one of two groups:
1. Patients in group one will receive dacarbazine once every 3 weeks for up to eight courses in the absence of disease progression.
2. Patients in group two will receive 5 days of G3139 followed by an infusion of dacarbazine. Treatment may be repeated every 3 weeks for up to eight courses in the absence of disease progression.

After completion of the study patients will be evaluated every 2 months for a maximum of 2 years from the time of randomization.

Intervention type

Drug

Phase

Not Specified

Drug names

Dacarbazine versus dacarbazine plus G3139 (Bcl-2 Antisense Oligonucleotide, Genasense™)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Measurable disease
2. No brain metastases
3. At least 4 weeks since biological therapy, radiation therapy or surgery
4. No previous chemotherapy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

750

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

Genta Incorporated
Berkeley Heights
NJ 07922
United States of America

Sponsor information

Organisation

Genta Incorporated (USA)

Sponsor details

2 Connell Drive
Berkeley Heights
NJ 07922
United States of America

Sponsor type

Industry

Website

http://www.genta.com

Funders

Funder type

Industry

Funder name

Genta Incorporated (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aventis (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes