A Phase II study of DJ-927 administered orally once every three weeks as second line therapy to subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of a platinum-based non-taxane regimen - N/A
- Conditions
- locally advanced or metastatic non small cell lung cancer following previous failure of a platinum-based non-taxane regimen
- Registration Number
- EUCTR2004-000696-34-HU
- Lead Sponsor
- Daiichi Pharmaceutical Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 37
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method