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
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