E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed Diffuse Large B-Cell Lymphoma |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the anti-tumor effectiveness of oral suberoylanilide hydroxamic acid (SAHA) as measured by overall objective response rate (ORR) in patients with relapsed DLBCL (de novo or transformed). |
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E.2.2 | Secondary objectives of the trial |
To assess response duration (RD), progression-free survival time (PFS), time to progression, time to response, and progression free survival rate at 3 months and 6 months; and to assess the safety of oral SAHA in this patient population. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Eligible patients must be ≥18 years with relapsed DLBCL (de novo or transformed)following standard first line chemotherapy and at least one salvage systemic therapy. Patients who have disease that is refractory to their last chemotherapy regimen are not eligible. Other eligibility criteria include: 3 months or longer without evidence of progression on the most recent treatment; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; ≥ 4 weeks from prior chemotherapy, radiation therapy, major surgery, or other investigational anticancer therapy; and adequate hematologic (absolute neutrophil count >1000/mm3, platelets > 75,000 /mm3), hepatic and renal function. |
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E.4 | Principal exclusion criteria |
Patients to be excluded from the trial if: had prior treatment with any HDAC inhibitor (e.g., Depsipeptide, MS-275, LAQ 824); had a response or stable disease less than 3 m to the most recent treatment; have failed more than 3 prior regimens ; have had an allogenenic transplantation. have certain co-mobility including HIV infection. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is ORR based on PET and CT scan findings in patients with measurable disease defined as those that can be accurately measured in at least one dimension of 2 cm by conventional CT scan. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |