AGENDA: Randomised, double-blind trial of dacarbazine with or without Genasense® (oblimersen, G3139) in advanced melanoma

ISRCTN	ISRCTN34237167
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

Study website

Contact information

Dr Claus Garbe
Scientific

University Medical Centre
Liebermeisterstr. 25
Tuebingen
72074
Germany

Phone	+49 707 1298 7110
Email	claus.garbe@med.uni-tuebingen.de

Study information

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
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
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

Sponsor information

Genta Incorporated (USA)
Industry

200 Connell Drive
Berkeley Heights
New Jersey
07922
United States of America

Phone	+1 908 219 3113
Email	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
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	14/02/2019	Yes	No

Editorial Notes

11/04/2019: Internal review.
14/02/2019: Publication reference added.