Non-small-cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
Verified date | January 2016 |
Source | Chipscreen Biosciences, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
Status | Completed |
Enrollment | 124 |
Est. completion date | December 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry. - Aged 18~75 years - Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown - With at least one measurable lesion - White blood cell count=4×10^9/L,platelet count=100×10^9/L and hemoglobin=11g/L - Life expectancy >3 months - Eastern Cooperative Oncology Group performance status of =1 at study entry - Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study - Have signed informed consent Exclusion Criteria: - Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or =Grade 2 sino-auricular heart-block,or =Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug - The size of fluid area detected by cardiac ultrasonography in cavum pericardium is =10mm during diastolic period - Organ transplant patients - Patients with active bleeding or new thrombotic diseases - Patients with body temperature >38.5? for more than 3 days - Total bilirubin >1.5 fold of upper limit of normal (ULN), ALT/AST>1.5 fold of ULN or serum creatine >1.5 fold of ULN - Patients with symptomatic brain-metastasis - Pregnant or lactating women - Patients with mental disorder |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing Chest Hospital, Capital Medical University | Beijing | Beijing |
China | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
China | The Second People's Hospital of Sichuan | Chengdu | Sichuan |
China | Jiangsu Cancer Hospital | Nanjing | Jiangsu |
China | Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University | Shanghai | Shanghai |
China | The first Hospital of China Medical University | Shenyang | Liaoning |
China | Hebei Provincial Tumor Hospital | Shijiazhuang | Hebei |
China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Chipscreen Biosciences, Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) | PFS is measured from the start of treatment until progression or death,whichever is first met | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 76 weeks | No |
Secondary | Progression-Free Survival Rate at 6 Months (6-M-PFS) | 6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month | 6 months | No |
Secondary | Object Response Rate (ORR) | ORR is defined as percentage of participants with Complete Response and Partial Response,assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) | Response is assessed once every 6 weeks (combination therapy period) for up to 12 weeks, and once every 8 weeks (maintenance therapy period) for up to 64 weeks | No |
Secondary | Duration of Response (DOR) | DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met | From the first date of response until the date of first documented progression, assessed up to 70 weeks | No |
Secondary | Overall Survival (OS) | OS is measured from the start of treatment until death | From date of randomization until the date of death from any cause, followed for up to 76 weeks | No |
Secondary | Time To Progression (TTP) during the maintenance therapy period | TTP is assessed for patients who complete the 12 weeks of combination therapy. It is measured from the start of maintenance therapy until the criteria of progression is met | From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks | No |
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