E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IV Metastatic Melanoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027480 |
E.1.2 | Term | Metastatic malignant melanoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of STA-4783 in combination with paclitaxel in comparison with paclitaxel alone, based on progression-free survival (PFS) |
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E.2.2 | Secondary objectives of the trial |
To assess overall survival (OS) To assess the objective response rate (ORR) To assess the clinical benefit rate (proportion of subjects who have CR or PR, or SD for at least 24 weeks) To assess the duration of objective response To further characterize the safety of STA-4783 in combination with paclitaxel in comparison with paclitaxel alone To further characterize the pharmacokinetics of STA-4783 in combination with paclitaxel |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Protocol No. 4783-08a: A Substudy Investigation of Electrocardiogram Readings in Subjects Participating in the Randomized, Double-Blind, Phase 3 Trial of STA-4783 (Elesclomol) in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic Melanoma; a Substudy of Master Protocol 4783-08; Version 2.0 dated 01 August 2008;
The primary objective of this study is to assess the cardiac repolarization profile in subjects receiving STA-4783 (elesclomol) with paclitaxel (elesclomol + paclitaxel) as compared to paclitaxel alone. |
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E.3 | Principal inclusion criteria |
A subject is eligible for the study if all of the following criteria are met: -must be at least 18 years of age -if female or childbearing potential or male, willing to use two forms of effective contraception during study treatment -must have histologically confirmed melanoma of cutaneous origin -must have Stage IV melanoma -must have Eastern Coorporative Oncology Group (ECOG) performance status of <or = 2 -must have measurable disease according to modified RECIST -if subject has received prior systemic therapy, must have evidence of persistent or progressive disease or the inability to tolerate previous treatment due to toxicity, in the opinion of the investigator -must not have received any prior cytotoxic chemotherapeutic agent for melanoma (eg, DTIC, carmustine, taxanes, microtubule inhibitors, hyperthermic isolated limb perfusion) -must not have received more than one regimen of kinase inhibitor, immunotherapy, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma -at least 4 weeks must have passed between the last kinase inhibitor, immunotherapy, biologic therapy, vaccine or investigational non-chemotherapeutic treatment (excluding anti-CTLA4) and the first dose of study medication -at least 8 weeks must have passed between the last treatment with anti-CTLA4 and the first dose of study medication -at least 2 weeks must have passed between the last radiotherapy treatment and the first dose of study medication. -must have a life expectancy of greater than 12 weeks -must have clinical laboratory values at screening as defined below: *LDH < or = to 2.0 x ULN *Hemoglobin >or = 8g/dL *Absolute neutrophil count > or = 1500/mm3 *Platelet count > or = to 100,000/mm3 *Creatinine < or = 1.5 mg/dL (NOTE: If creatinine is > 1.5 mg/dL, subject is eligible if creatinine clearance > or = to 60 mL/min using the Cockgroft-Gault equation) *Total bilirubin < or = to 1.2 mg/dL *Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < or = to 2.5 x ULN -must have ability to understand and the willingness to sign a written informed consent document
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E.4 | Principal exclusion criteria |
A subject is excluded from the study if any of the folllowing criteria are met: -female subjects who are pregnant or nursing -presence or history (> or = 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ -presence of an active infection requiring intravenous antibiotics, a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, pneumonia, septicemia) which required systemic antibiotic treatment within 2 weeks prior to the first dose of study medication -presence of a potentially drug-induced peripheral neuropathy that is assessed as Grade 2 or greater based on the NCI CTCAE criteria version 3.0 -history of or clinical symptoms of central nervous system metastases -presence of any brain metastases (as determined by contrast computed tomography (CT) or magnetic resonance imaging (MRI) scan performed during screening -presence of clinically significant cardiac arrhythmias -known to be HIV positive -needs chronic immunosuppressive therapy (eg, cyclophosphamide following transplantation) -has had surgery within 2 weeks (1 week for minor surgery, eg, procedures requiring only local anesthetics) prior to the first dose of study medication -use of "complementary" anti-cancer therapy (prescription or over the counter, including herbal remedies or high-dose antioxidants) within 2 weeks prior to the first dose of study medication and for the duration of the study -presence of a serious concurrent illness or other condition (eg, psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is Progression Free Survival (PFS) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 70 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |