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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/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)
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
Secondary ID [1] 0 0
AC-052-281
Universal Trial Number (UTN)
Trial acronym
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 - Bosentan
Treatment: Drugs - Placebo

Experimental: Bosentan -

Placebo Comparator: Placebo -


Treatment: Drugs: Bosentan
Bosentan 500 mg bid

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria.
Timepoint [1] 0 0
6 weekly
Secondary outcome [1] 0 0
• 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
Timepoint [1] 0 0
6 weekly

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 Tracleer™

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

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment hospital [2] 0 0
Sydney Haematology and Oncology Unit - Hornsby
Recruitment hospital [3] 0 0
Cabrini Hopsital - Oncology Department - Malvern
Recruitment hospital [4] 0 0
New Castle Melanoma Unit - New Castle
Recruitment hospital [5] 0 0
Mount Medical Centre - Perth
Recruitment hospital [6] 0 0
Redcliffe Hospital - Dept Oncology & Palliative Care - Redcliffe
Recruitment hospital [7] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [8] 0 0
Pacific Private Clinic - Southport
Recruitment hospital [9] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 0 0
Sydney Cancer Centre, Royal Prince Alfred Hospital - Sydney
Recruitment hospital [11] 0 0
Westmead Hospital - Department of Oncology - Westmead
Recruitment hospital [12] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
VIC 3220 - Geelong
Recruitment postcode(s) [2] 0 0
NSW - Hornsby
Recruitment postcode(s) [3] 0 0
VIC 2144 - Malvern
Recruitment postcode(s) [4] 0 0
NSW - New Castle
Recruitment postcode(s) [5] 0 0
WA - Perth
Recruitment postcode(s) [6] 0 0
QLD 4020 - Redcliffe
Recruitment postcode(s) [7] 0 0
QLD 4001 - South Brisbane
Recruitment postcode(s) [8] 0 0
QLD 4215 - Southport
Recruitment postcode(s) [9] 0 0
NSW - St Leonards
Recruitment postcode(s) [10] 0 0
NSW - Sydney
Recruitment postcode(s) [11] 0 0
NSW 2145 - Westmead
Recruitment postcode(s) [12] 0 0
NSW - Wollongong

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01009177
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andjela Kusic-Pajic, MD
Address 0 0
Actelion Pharmaceuticals Australia Pty. Ltd
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01009177