Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu
Trial record 1 of 1 for:    NCT01009177
Previous Study | Return to List | Next Study

Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01009177
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : April 30, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Bosentan Drug: Placebo Phase 2

Detailed Description:

This is a randomized, double-blind (1:1 bosentan : placebo) trial to evaluate the effect of bosentan in combination with DTIC on TTP or death in patients with metastatic melanoma stage IV.

The patients will receive study medication (bosentan or placebo) and DTIC for 35 weeks to 105 weeks; the study will be completed when 66 events (tumor progression, death due to underlying disease, other/additional anti-tumor therapy) have been observed.

Study drug will be administered orally, 500 mg twice a day. DTIC will be given once every three weeks in a dosage of 1000 mg/m2 intravenously (i.v.) or in accordance with the Institution's DTIC treatment protocol.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Bosentan

Arm Intervention/treatment
Experimental: Bosentan Drug: Bosentan
Bosentan 500 mg bid

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. [ Time Frame: 6 weekly ]

Secondary Outcome Measures :
  1. • 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 [ Time Frame: 6 weekly ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009177

Layout table for location information
Barwon Health - The Geelong Hospital
Geelong, Australia, VIC 3220
Sydney Haematology and Oncology Unit
Hornsby, Australia, NSW
Cabrini Hopsital - Oncology Department
Malvern, Australia, VIC 2144
New Castle Melanoma Unit
New Castle, Australia, NSW
Mount Medical Centre
Perth, Australia, WA
Redcliffe Hospital - Dept Oncology & Palliative Care
Redcliffe, Australia, QLD 4020
Mater Adult Hospital
South Brisbane, Australia, QLD 4001
Pacific Private Clinic
Southport, Australia, QLD 4215
Royal North Shore Hospital
St Leonards, Australia, NSW
Sydney Cancer Centre, Royal Prince Alfred Hospital
Sydney, Australia, NSW
Westmead Hospital - Department of Oncology
Westmead, Australia, NSW 2145
Southern Medical Day Care Centre
Wollongong, Australia, NSW
Sponsors and Collaborators
Layout table for investigator information
Study Director: Andjela Kusic-Pajic, MD Actelion Pharmaceuticals Australia Pty. Ltd

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Actelion Identifier: NCT01009177    
Other Study ID Numbers: AC-052-281
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Keywords provided by Actelion:
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action