Condition category
Cancer
Date applied
14/04/2008
Date assigned
09/06/2008
Last edited
09/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.genta.com/agenda.html

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 measures

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

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

http://www.genta.com

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

Results - basic reporting

Publication summary

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)

Publication citations

Additional files

Editorial Notes