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 designPhase III, multicentre, randomised (1:1), double-blind, placebo-controlled, parallel-group trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not currently available, please refer to the contact details below to request additional information.
Scientific titleA 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 acronymAGENDA
Study objectivesThis 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) studiedMelanoma
InterventionProtocol 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Genasense® and dacarbazine
Primary outcome measureProgression-free survival and overall survival
Secondary outcome measures1. 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 date01/07/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2007
Date of final enrolment31/12/2008

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.