Mesothelioma MedDRA version: 7.1 Level: LLT Classification code 10027406
Conditions
Interventions
Product Name: suberoylanilide hydroxamic acid (SAHA)
Product Code: MK-0683/L-001079038
Pharmaceutical Form: Capsule*
CAS Number: 149647-78-9
Current Sponsor code: MK-0683/L-00107938
Other descriptive
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient must have a histologically and/or cytologically confirmed diagnosis of epithelial, sarcomatoid, or mixed histology malignant pleural mesothelioma, which has progressed or relapsed following standard treatment which included pemetrexed in combination with either cisplatin or carboplatin. The most recent regimen must have contained pemetrexed Patient has had no more than one previous systemic therapy regimen other than pemetrexed in combination with cisplatin or carboplatin; the most recent regimen must have contained pemetrexed Patient must have at least 1 lesion that can be measured by using the modified RECIST [10], i.e., is at least 1.5 cm in diameter on a spiral computerized tomography (CT) scan. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient had prior treatment with an HDAC inhibitor (e.g., Depsipeptide, MS 275, LAQ-824, PXD-101, and valproic acid). Patient has an active infection or had received intravenous antibiotic, antiviral, or antifungal medications within 2 weeks prior to the start of study drug. Patients with a "currently active" second malignancy other than non-melanoma skin cancers and carcinoma in situ of the cervix are not eligible. Patients are not considered to have a "currently active" second malignancy if they have completed therapy for the second malignancy and are disease free from prior malignancies for >5 years. Patient has uncontrolled brain metastases, e.g., previously treated brain metastases that is not stable in the last 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the overall survival associated with L-001079038 plus best supportive care versus that associated with placebo plus best supportive care for the treatment of patients with advanced malignant pleural mesothelioma who have failed prior chemotherapy that has included pemetrexed in combination with either cisplatin or carboplatin, and to determine the overall safety and toxicity of L-001079038 in this population;Secondary Objective: To compare between L-001079038 plus best supportive care versus placebo plus best supportive care for the treatment of patients with advanced malignant mesothelioma who have failed prior chemotherapy that included pemetrexed in combination with either cisplatin or carboplatin with respect to: a. Overall ORR; b. Time-to-progression; c. Dyspnea score of lung cancer symptom scale modified for mesothelioma (LCSS-Meso) at Week 12; and d. Percent change from baseline in forced vital capacity (FVC) at Week 12. ;Primary end point(s): The primary efficacy endpoint of this study is overall survival. Survival is generally considered to be the best measurement of an oncology drug’s effectiveness. | — |
Countries
Germany, Greece, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed