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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00518895




Registration number
NCT00518895
Ethics application status
Date submitted
14/08/2007
Date registered
21/08/2007
Date last updated
6/11/2011

Titles & IDs
Public title
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
Scientific title
A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
Secondary ID [1] 0 0
GM307
Secondary ID [2] 0 0
AGENDA
Universal Trial Number (UTN)
Trial acronym
AGENDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dacarbazine plus Genasense
Treatment: Drugs - dacarbazine plus placebo

Experimental: A - Dacarbazine with Genasense

Active Comparator: B - Dacarbazine with placebo


Treatment: Drugs: dacarbazine plus Genasense
Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. 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.

Treatment: Drugs: dacarbazine plus placebo
Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will 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/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival and overall survival
Timepoint [1] 0 0
Every 42 days from date of randomization during protocol therapy
Secondary outcome [1] 0 0
Response rate, durable response rate, duration of response, safety
Timepoint [1] 0 0
Response and progression every 42 days from date of randomization during protocol therapy

Eligibility
Key inclusion criteria
- Histologically confirmed diagnosis of melanoma

- Progressive disease that is not surgically resectable, or metastatic Stage IV

- Low-normal LDH, defined as = 0.8 times the upper limit of normal

- No prior chemotherapy

- Measurable disease

- ECOG performance status = 1

- 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

- Prior immunotherapy allowed

- Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense
treatment

- Primary ocular or mucosal melanoma

- Bone-only metastatic disease

- History or presence of brain metastasis or leptomeningeal disease

- Significant medical disease other than cancer

- Organ allograft

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Cancer Center, Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Iowa
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United States of America
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Massachusetts
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United States of America
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Montana
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United States of America
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New Jersey
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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Austria
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Innsbruck
Country [12] 0 0
Austria
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St. Polten
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Austria
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Wien
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Canada
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Ontario
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Czech Republic
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Prague
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France
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Besancon
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France
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Bordeaux
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France
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Boulogne-Billancourt
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France
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Clermont Ferrand
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France
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Dijon
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France
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Grenoble
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France
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Le Mans
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Montpellier
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France
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Nantes
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France
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Paris
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France
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Reims
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France
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Rouen
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France
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Villejuif
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Erfurt
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Jena
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Germany
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Koln
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Germany
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Leipzig
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Germany
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Lubeck
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Marburg
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Germany
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Munster
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Germany
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Plauen
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Germany
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Quedlinburg
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Germany
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Regensburg
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Germany
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Tubingen
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Italy
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Coppitto-L'Aquila
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Italy
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Milano
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Italy
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Napoli
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Italy
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Rome
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Italy
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Siena
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Poland
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Gdansk
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Poland
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Poznan
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Navarra
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Switzerland
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Zurich
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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United Kingdom
State/province [64] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genta Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being performed to prospectively determine whether dacarbazine plus Genasense
is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with
advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit
of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial
of dacarbazine plus Genasense.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00518895
Trial related presentations / publications
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].
Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. doi: 10.1200/JCO.2006.06.0483. Epub 2006 Sep 11.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00518895