E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histologically-confirmed advanced solid tumours for which no standard therapy exists or has failed therapy |
|
MedDRA Classification |
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 find an Maximum Tolerated Dose and Recommended Dose for NC-6004 in patients with solid tumours |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability profile of NC-6004 To determine any evidence of anti-tumour activity To explore the pharmacokinetic profile of NC-6004
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male and female patients aged ≥ 18 years Histologically-confirmed advanced solid tumours for which no standard therapy exists or has failed therapy Only one previous course of platinum with maximum doses as follows: - Cisplatin 450 mg/m2 - Oxaliplatin 960 mg /m2 - Carboplatin 42 mg/ml.min cumulative AUC Disease evaluable for response (including tumour markers where applicable). If the only measurable lesion is in a previously irradiated field, clear cut progression after radiation must be documented Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2 Life expectancy of at least 12 weeks Adequate bone marrow function - Absolute neutrophil count (ANC) ≥ 1500 cells/μL - Platelets ≥ 100,000 cells/μL - Haemoglobin ≥ 9.0g/dL Adequate renal function with chromium-51 (51Cr)–EDTA ≥60 mL/min If pre-menopausal, willing to use barrier contraception during study participation (except for patients with bilateral tubal ligation or who have undergone hysterectomy or other sterilisation procedure) Written informed consent to participate in the trial
|
|
E.4 | Principal exclusion criteria |
Known severe hypersensitivity to cisplatin or any of the excipients of this product More than one previous course of platinum therapy Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to <20% of bone marrow), immunotherapy, or corticosteroids (greater than 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Serum bilirubin >1.5 times the upper limit of the reference range (ULRR) in the absence of liver metastases Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases Serum calcium above the ULRR As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease) Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study Pregnancy or breastfeeding. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment Evidence of ototoxicity as assessed by audiometry or other neurotoxicity ≥ Grade 2 Concurrent treatment with other experimental drugs and/or anticancer agents
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of Dose Limiting Toxicity (according to NCI Common Toxicity Criteria Version 3.0) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
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) | No |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
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
|
Sooner of either: - Last visit of last subject in the study (28 days following last administration of IMP) - Assessment of toxicity following last recruited patient being treated for minimum of 6 cycles (where patient continues IMP treatment for compassionate reasons) |
|
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 |