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 (NCT) | NCT00016263 |
| Protocol serial number | GM301 |
| Sponsor | Genta Incorporated (USA) |
| Funders | Genta Incorporated (USA), Aventis (USA) |
- 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
Scientific
Genta Incorporated
2 Connell Drive
Berkeley Heights
NJ 07922
United States of America
| Phone | +1 888 322 2264 |
|---|---|
| clinicaltrials@genta.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dacarbazine versus dacarbazine plus G3139 (Bcl-2 Antisense Oligonucleotide, Genasense™) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
NJ 07922
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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
