Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836679
• Other study ID #: CDM204
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2013
• Last updated: January 28, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• 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

Clinical Trial 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.

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 safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• Chidamide
Given orally
• Paclitaxel
Given IV
• Carboplatin
Given IV
• Placebo
Given orally

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chipscreen Biosciences, Ltd.

Country where clinical trial is conducted

China, 

Outcome

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