Randomised study of dacarbazine versus dacarbazine plus G3139 (Bcl-2 Antisense Oligonucleotide, Genasense™) in patients with advanced malignant melanoma

ISRCTN	ISRCTN34651483
DOI	https://doi.org/10.1186/ISRCTN34651483
ClinicalTrials.gov number	NCT00016263
Secondary identifying numbers	GM301

Submission date: 06/11/2002
Registration date: 06/11/2002
Last edited: 08/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stan Frankel
Scientific

Genta Incorporated
2 Connell Drive
Berkeley Heights
NJ 07922
United States of America

Phone	+1 888 322 2264
Email	clinicaltrials@genta.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised study of dacarbazine versus dacarbazine plus G3139 (Bcl-2 Antisense Oligonucleotide, Genasense™) in patients with advanced malignant melanoma
Study objectives	To compare the effectiveness of dacarbazine with or without oblimersen (G3139) in treating patients who have advanced malignant melanoma.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dacarbazine versus dacarbazine plus G3139 (Bcl-2 Antisense Oligonucleotide, Genasense™)
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2000
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	750
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

United States of America

Study participating centre

Genta Incorporated

Berkeley Heights
NJ 07922
United States of America

Sponsor information

Genta Incorporated (USA)
Industry

2 Connell Drive
Berkeley Heights
NJ 07922
United States of America

Website	http://www.genta.com

Funders

Funder type

Industry

Genta Incorporated (USA)

No information available

Aventis (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/10/2006	08/02/2019	Yes	No

Editorial Notes

08/02/2019: Publication reference added.
25/01/2019: No publications found. Verifying results with the principal investigator