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

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: Bosentan (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Andjela Kusic-Pajic, MD, Study Director, Affiliation: Actelion Pharmaceuticals Australia Pty. Ltd

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria.

Secondary outcome: • 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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Barwon Health - The Geelong Hospital, Geelong VIC 3220, Australia

Sydney Haematology and Oncology Unit, Hornsby NSW, Australia

Cabrini Hopsital - Oncology Department, Malvern VIC 2144, Australia

New Castle Melanoma Unit, New Castle NSW, Australia

Mount Medical Centre, Perth WA, Australia

Redcliffe Hospital - Dept Oncology & Palliative Care, Redcliffe QLD 4020, Australia

Mater Adult Hospital, South Brisbane QLD 4001, Australia

Pacific Private Clinic, Southport QLD 4215, Australia

Royal North Shore Hospital, St Leonards NSW, Australia

Sydney Cancer Centre, Royal Prince Alfred Hospital, Sydney NSW, Australia

Westmead Hospital - Department of Oncology, Westmead NSW 2145, Australia

Southern Medical Day Care Centre, Wollongong NSW, Australia

Additional Information

Starting date: September 2005
Last updated: April 28, 2015

Page last updated: August 23, 2015

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