locally advanced or metastatic non small cell lung cancer following previous failure of a platinum-based non-taxane regimen
Conditions
Interventions
Product Name: DJ-927
Product Code: DJ-927
Pharmaceutical Form: Capsule*
INN or Proposed INN: No INN or proposed INN available
Current Sponsor code: DJ-927
Concentration unit: mg milligram(s)
Concentra
Sponsors
Daiichi Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess anti-tumour activity (RECIST criteria) of DJ-927 following previous failure of a platinum-based non-taxane regimen;Secondary Objective: 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 ;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 | — |
Countries
Hungary
Outcome results
None listed