E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
locally advanced or metastatic non small cell lung cancer following previous failure of a platinum-based non-taxane regimen |
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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 assess anti-tumour activity (RECIST criteria) of DJ-927 following previous failure of a platinum-based non-taxane regimen |
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E.2.2 | Secondary objectives of the trial |
To assess: 1. Duration of response 2. Time to tumour progression 3. Time to treatment failure 4. Median survival time and 12-month survival rate 5. Qualitative and quantitative toxicities
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Histologically and/or cytologically confirmed locally advanced or metastatic NSCLC 2. No more than one prior systemic platinum-based (non-taxane) chemotherapy regimen for locally advanced or metastatic NSCLC 3. Demonstrated tumour progression at time of entry into study 4. Measurable Disease (RECIST). FOr patients who have received prior radiotherapy, measurable disease must be located outside the previously-irradiated field 5. Age 18 years or over 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Reasonable survival expectation greater than or equal to 12 weeks 8. Adequate bone marrow, liver and renal function defined as: a) absolute neutrophil count greater than or equal to 1.5 x 109/L b) platelet count greater than or equal to 100 x 10 9/L c) AST and ALT less than or equal to 2.5x upper limit of normal (ULN) (or <5x ULN when liver metastases are present) d) total bilirubin value less than or equal to 1.5x ULN e) serum creatinine value less than or equal to 1.5x ULN 9. Fully recovered from any previous surgery (at least 4 weeks since major surgery) 10. Using double barrier contraception (males and females alike) (if applicable). A negative pregnancy test must be documented at the screening/baseline visit for women of childbearing potential 11. Has signed a voluntary written informed consent and has the ability to understand and agree to the requirements of the study
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E.4 | Principal exclusion criteria |
1. No measurable disease 2. Continuing toxicities related to previous anti-tumour therapy (e.g., radiation therapies, biological therapies and investigational products), and administration of concurrent or previous myelosuppressive therapy within 4 weeks (or 6 weeks for prior treatment with nitrosourea, mitomycin C or carboplatin) 3. Prior taxane therapy 4. Prior wide field radiotherapy (>25% of marrow) within the previous 4 weeks, or radiotherapy to limited portals within 2 weeks 5. History of known or suspected CNS metastases 6. History of other malignancy (except resected non-melanoma skin cancer or resected carcinoma in situ of the cervix), unless in complete remission and off all therapy of that disease for a minimum of 2 years 7. Concurrent serious infection 8. Concurrent severe or uncontrolled underlying medical disease unrelated to the tumour that is likely to compromise subject safety and affect the outcome of the study 9. History of any severe or life-threatening hypersensitivity reaction 10. Neurotoxicity greater than or equal to Grade 2 11. Pregnant or lactating women 12. Clinically significant dysphagia or malabsorption that precludes the ability to comply with oral medication and absorption of DJ-927 13. Any contra-indication including extensive intestinal surgery that would impair small intestinal absorption of taxanes Diarrhoea (greater than or equal to Grade 2) 14. Currently enrolled in an investigational device or drug trial, or less than 30 days since completing an investigational device or drug trial 15. Recent history (within 6 months) of chronic alcohol or drug abuse which may compromise the subject's safety or ability to participate in study activities 16. History of psychiatric disorder that prevents subjects from providing informed consent or following protocol instructions |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Overall tumour response 2. Duration of response 3. Time to tumour progression 4. Time to treatment failure 5. Median survival time and 12-month survival rate 6. Treatment-related toxicities 7. Evaluation of plasma pharmacokinetics of DJ-927 |
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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 | No |
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 | No |
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) | 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 | No |
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
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Last visit of last subject enrolled in 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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
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 | 4 |