AGENDA: Randomised, double-blind trial of dacarbazine with or without Genasense® (oblimersen, G3139) in advanced melanoma
ISRCTN | ISRCTN34237167 |
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DOI | https://doi.org/10.1186/ISRCTN34237167 |
ClinicalTrials.gov number | NCT00518895 |
Secondary identifying numbers | GM307 |
- Submission date
- 14/04/2008
- Registration date
- 09/06/2008
- Last edited
- 11/04/2019
- 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 Claus Garbe
Scientific
Scientific
University Medical Centre
Liebermeisterstr. 25
Tuebingen
72074
Germany
Phone | +49 707 1298 7110 |
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claus.garbe@med.uni-tuebingen.de |
Study information
Study design | Phase III, multicentre, randomised (1:1), double-blind, placebo-controlled, parallel-group trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not currently available, please refer to the contact details below to request additional information. |
Scientific title | A multicentre, randomised, double-blind study of dacarbazine with or without Genasense® in chemotherapy-naïve subjects with advanced melanoma and low lactate dehydrogenase (LDH) (The AGENDA Trial) |
Study acronym | AGENDA |
Study objectives | This study is being performed to prospectively determine whether dacarbazine plus Genasense® is significantly better than dacarbazine plus placebo in chemotherapy-naïve subjects with advanced melanoma and baseline lactate dehydrogenase (LDH) less than or equal to 0.8 x upper limit of normal (ULN). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense®. |
Ethics approval(s) | USA: The University of Texas, M.D. Anderson Cancer Center, Office of Protocol Review, approved in July 2007 France: The Salvator Hospital, Comite de Protection des Personnes Sud-Mediterranee I, Marseille, approved in October 2007 Other sites will also obtain ethics approval before recruitment of participants. |
Health condition(s) or problem(s) studied | Melanoma |
Intervention | Protocol therapy is administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense® group receive Genasense® 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1,000 mg/m^2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense® infusion. Subjects in the dacarbazine plus placebo group receive placebo (that is, locally available commercial 0.9% sodium chloride injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m^2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. In both treatment groups, subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Genasense® and dacarbazine |
Primary outcome measure | Progression-free survival and overall survival |
Secondary outcome measures | 1. Response rate 2. Durable response rate 3. Duration of response 4. Safety Follow-up every 2 months for up to 24 months from date of randomisation. |
Overall study start date | 01/07/2007 |
Completion date | 31/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 300 |
Key inclusion criteria | 1. At least 18 years of age, both males and females 2. Histologically confirmed diagnosis of melanoma 3. Progressive disease that is not surgically resectable, or metastatic Stage IV disease 4. Low LDH (defined as LDH less than or equal to 0.8 x ULN) 5. Chemotherapy naïve 6. Measurable disease 7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 8. At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy 9. Adequate organ function |
Key exclusion criteria | 1. Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense® treatment 2. Primary ocular or mucosal melanoma 3. Bone-only metastatic disease 4. History or presence of brain metastasis or leptomeningeal disease 5. Significant medical disease other than cancer 6. Organ allograft |
Date of first enrolment | 01/07/2007 |
Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Australia
- Austria
- Canada
- Czech Republic
- France
- Germany
- Italy
- Spain
- Switzerland
- United Kingdom
- United States of America
Study participating centre
University Medical Centre
Tuebingen
72074
Germany
72074
Germany
Sponsor information
Genta Incorporated (USA)
Industry
Industry
200 Connell Drive
Berkeley Heights
New Jersey
07922
United States of America
Phone | +1 908 219 3113 |
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MEDINFO@genta.com | |
Website | http://www.genta.com |
Funders
Funder type
Industry
Genta Incorporated (USA)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 10/10/2006 | 14/02/2019 | Yes | No |
Editorial Notes
11/04/2019: Internal review.
14/02/2019: Publication reference added.