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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
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
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
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Texas
Country [11] 0 0
Austria
State/province [11] 0 0
Innsbruck
Country [12] 0 0
Austria
State/province [12] 0 0
St. Polten
Country [13] 0 0
Austria
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Wien
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Canada
State/province [14] 0 0
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
Trial website
Trial related presentations / publications
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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00518895