Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Claus Garbe
ORCID ID
Contact details
University Medical Centre
Liebermeisterstr. 25
Tuebingen
72074
Germany
+49 707 1298 7110
claus.garbe@med.uni-tuebingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00518895
Protocol/serial number
GM307
Study 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)
Acronym
AGENDA
Study hypothesis
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
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.
Study design
Phase III, multicentre, randomised (1:1), double-blind, placebo-controlled, parallel-group trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not currently available, please refer to the contact details below to request additional information.
Condition
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
Phase
Phase III
Drug names
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 trial start date
01/07/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Australia, Austria, Canada, Czech Republic, France, Germany, Italy, Spain, Switzerland, United Kingdom, United States of America
Trial participating centre
University Medical Centre
Tuebingen
72074
Germany
Sponsor information
Organisation
Genta Incorporated (USA)
Sponsor details
200 Connell Drive
Berkeley Heights
New Jersey
07922
United States of America
+1 908 219 3113
MEDINFO@genta.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Genta Incorporated (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
Basic results (scientific)
Publication list
Abstract: Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 (Abstract T-26)