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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01009177
Registration number
NCT01009177
Ethics application status
Date submitted
14/10/2009
Date registered
6/11/2009
Date last updated
30/04/2015
Titles & IDs
Public title
Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine
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Secondary ID [1]
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AC-052-281
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bosentan
Treatment: Drugs - Placebo
Experimental: Bosentan -
Placebo comparator: Placebo -
Treatment: Drugs: Bosentan
Bosentan 500 mg bid
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria.
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Assessment method [1]
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Timepoint [1]
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6 weekly
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Secondary outcome [1]
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• Tumor response rate • Duration of overall response • Best overall response • Survival will be assessed at 12 months after initiation of study drug and every year thereafter for 5 years
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Assessment method [1]
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Timepoint [1]
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6 weekly
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Eligibility
Key inclusion criteria
1. Male or female patients 18 years of age or older
2. Histologically proven malignant melanoma (Balch et al., J. Clin Oncol. 19(16): 3635-48, 2001) with stage IV measurable disease as defined by RECIST criteria (Therasse et al., J Natl Cancer Inst, 92(3): 205-16, 2000).
3. Patients with prior radiation therapy (> 30 days prior to study drug initiation) will be allowed provided the indicator lesion(s) used for this study was (were) outside the field of radiation or represent new lesions not previously irradiated.
4. Patients who had no prior therapy with DTIC.
5. Patients with cutaneous melanoma lesions must consent to having a biopsy obtained during the screening period and at the end of treatment for exploratory analysis of endothelin receptor expression. Biopsies obtained prior to the study that have been frozen in accordance with procedures specified for this protocol may be used.
6. ECOG performance status (= 2)
7. Life expectancy > 12 weeks
8. Female patients must be non-pregnant, non-breast feeding, and either post menopausal, surgically sterile, or practicing a reliable method of contraception (hormonal methods alone are not sufficient)
9. Provide written informed consent
10. Willing to return to study center for follow up
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. ALT and/or AST > 3 × the upper limit of normal (ULN) at screening OR ALT and /or AST > 2 x ULN and total bilirubin > 2.0 mg/dl at screening
2. Lactate dehydrogenase > 1.5 x ULN
3. Hemoglobin >30% below the lower limit of normal
4. Systolic blood pressure < 85 mmHg
5. NYHA class III/IV congestive heart failure
6. Any prior chemotherapy, biological therapy or immunotherapy for stage IV metastatic disease.
7. Received immunotherapy < 30 days before treatment start (completed adjuvant immunotherapy for previous resected metastatic disease is allowed)
8. Concurrent use of calcineurin inhibitors (cyclosporine A, tacrolimus), sirolimus, fluconazole or glibenclamide (glyburide) or expected to receive any of these drugs during the study at inclusion and during the study.
9. History of other malignancy in the last 5 years, with the exception of squamous cell carcinoma of the skin treated with local resection and basal cell carcinoma
10. CNS metastases or carcinomatous meningitis
11. Ocular melanoma
12. Known hypersensitivity to any excipients of Tracleerâ„¢
13. Prior therapy with bosentan
14. Use of therapy with another investigational drug within 4 weeks of the start of dosing with bosentan or plan to receive such treatment during the study
15. Known drug or alcohol dependence or any other factor that will interfere with the conduct of the study
16. Any standard contraindications for the use of DTIC as per Australian package insert
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2008
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Barwon Health - The Geelong Hospital - Geelong
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Recruitment hospital [2]
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Sydney Haematology and Oncology Unit - Hornsby
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Recruitment hospital [3]
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Cabrini Hopsital - Oncology Department - Malvern
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Recruitment hospital [4]
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New Castle Melanoma Unit - New Castle
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Recruitment hospital [5]
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Mount Medical Centre - Perth
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Recruitment hospital [6]
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Redcliffe Hospital - Dept Oncology & Palliative Care - Redcliffe
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Recruitment hospital [7]
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [8]
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Pacific Private Clinic - Southport
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Recruitment hospital [9]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [10]
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Sydney Cancer Centre, Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [11]
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Westmead Hospital - Department of Oncology - Westmead
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Recruitment hospital [12]
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Southern Medical Day Care Centre - Wollongong
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Recruitment postcode(s) [1]
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VIC 3220 - Geelong
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Recruitment postcode(s) [2]
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NSW - Hornsby
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Recruitment postcode(s) [3]
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VIC 2144 - Malvern
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Recruitment postcode(s) [4]
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NSW - New Castle
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Recruitment postcode(s) [5]
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WA - Perth
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Recruitment postcode(s) [6]
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QLD 4020 - Redcliffe
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Recruitment postcode(s) [7]
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QLD 4001 - South Brisbane
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Recruitment postcode(s) [8]
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QLD 4215 - Southport
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Recruitment postcode(s) [9]
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NSW - St Leonards
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Recruitment postcode(s) [10]
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NSW - Sydney
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Recruitment postcode(s) [11]
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NSW 2145 - Westmead
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Recruitment postcode(s) [12]
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NSW - Wollongong
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Actelion
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is designed as a multicenter, double blind, parallel-group, placebo-controlled, randomized, event driven Phase II study of DTIC with or without bosentan as first-line treatment in patients with stage IV melanoma.
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Trial website
https://clinicaltrials.gov/study/NCT01009177
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Trial related presentations / publications
Kefford RF, Clingan PR, Brady B, Ballmer A, Morganti A, Hersey P. A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy. Mol Cancer. 2010 Mar 30;9:69. doi: 10.1186/1476-4598-9-69.
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Public notes
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Contacts
Principal investigator
Name
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Andjela Kusic-Pajic, MD
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Address
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Actelion Pharmaceuticals Australia Pty. Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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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/NCT01009177
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