Status:
COMPLETED
Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Chipscreen Biosciences, Ltd.
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01836679
Start Date
April 1 2013
End Date
December 1 2015
Last Update
February 1 2016
Active Locations (8)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149
3
Hebei Provincial Tumor Hospital
Shijiazhuang, Hebei, China, 050011
4
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009